NIH Clinical Center Search the Studies: Study Number, Study Title

Protocol Details

Long-Term Follow-Up Of Subjects With CHC Who Achieved A Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

18-DK-0091

Sponsoring Institute

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18 Years
Max Age: 120 Years

Referral Letter Required

No

Population Exclusion(s)

Pregnant Women;
Children

Keywords

Natural History;
Hepatitis C Virus;
Hepatocellular Carcinoma;
Fibrosis;
Immune Response

Recruitment Keyword(s)

None

Condition(s)

Diabetes Mellitus;
Hepatitis C, Chronic;
Cardiovascular Diseases

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

Drug: Epclusa

Supporting Site

National Institute of Diabetes and Digestive and Kidney Diseases

Background:

Chronic hepatitis C infects the liver. It may scar the liver. This is called cirrhosis and may lead to liver cancer or death. Current chronic hepatitis C treatments cure most people. But some keep getting complications even after it is cured. Researchers want to study why.

Objective:

To study the course and complications of liver disease after cure of hepatitis C infection.

Eligibility:

Adults 18 years and older infected with chronic hepatitis C virus who were never treated or were treated and not cured and those who were cured

Design:

Participants will be screened with:

Blood and urine tests

Questionnaires

Liver ultrasound

Fibroscan. A probe vibrates the liver, testing stiffness.

In Phase 1, people with chronic hepatitis C will:

Have a 3-day hospital admission to repeat some screening tests and have a liver biopsy. A small piece of liver is removed by needle passed through the skin.

Take 1 tablet containing 2 hepatitis C drugs once a day for 12 weeks.

Repeat some blood tests at 3 visits in those 12 weeks while on treatment, then 4 additional visits in the next 24 weeks with more blood work collected.

Phase 1 participants who test negative for hepatitis C and all other eligible participants will enter Phase 2.

Phase 2 participants will have a visit every 24 weeks for 10 years. These may include:

Repeats of screening tests

Questionnaires

Scans

Stool tests

Chest x-ray

Heart function test

Endoscopy. A tube guides a camera into the upper digestive system.

At about 5 years, participants will have another liver biopsy.

Some participants will give separate consent for genetic testing and a special blood procedure.

--Back to Top--

Eligibility

INCLUSION CRITERIA:

Phase I Treatment

-Male or female >= 18 years of age

-Either treatment naive or experienced defined as failure of a prior course of interferon-based and ribavirin, DAA plus interferon and DAA only

-Confirmation of chronic HCV infection documented by:

--A positive HCV RNA or positive HCV genotyping test at least 6-months prior to the Baseline/Day 1 visit

--A liver biopsy performed prior to screening visit showing evidence of chronic hepatitis.

-Subjects must have the following laboratory parameters at screening:

--ALT <= 10 x the upper limit of normal (ULN)

--AST <= 10 x ULN

--Total bilirubin <2.5 mg/dL, Direct bilirubin <= 1.5 ULN

--Platelets >= 50,000 K/mm3

--HbA1c <= 8.5%

--Hemoglobin >= 10g/dL

--Albumin >= 3g/dL

--INR <= 1.5 unless subject has known hemophilia or is stable on an anticoagulant regimen affecting INR.

--HCV RNA positive at screening.

-Subjects must be of generally good health, with the exception of chronic HCV infection, as determined by the Investigator.

Phase II Follow-up

-Male or female >= 18 years of age.

-SVR24 following therapy with a direct acting antiviral agent regimen and available liver biopsy performed prior to treatment.

-Subject must be of generally good health as determined by the Investigator.

EXCLUSION CRITERIA:

An individual who meets any of the following criteria will be excluded from participation in this study:

Phase I Treatment

-Pregnancy or lactation

-Inability to practice one form of adequate contraction for females of childbearing potential

-Prior treatment with a NS5a agent

-Current or prior history of any of the following:

--Clinically significant illness (other than HCV) or any other major medical disorder that may interfere with subject treatment, assessment, or compliance with the protocol; subjects currently under evaluation for a potentially clinically significant illness (other than HCV) are also excluded

--Gastrointestinal disorder or post-operative condition that could interfere with the absorption of the study drug

--Decompensated liver disease as defined by serum bilirubin >= 2.5 mg/dL (with direct bilirubin >= 1.5 mg/dL), INR >1.5 a serum albumin of less than 3 g/dL, or a history of ascites, hepatorenal syndrome, variceal bleeding, or hepatic encephalopathy

--Solid organ transplantation

--Significant pulmonary disease, significant cardiac disease

-History of malignancy or treatment for a malignancy within the past 3 years that is associated with a life expectancy <5 years (except adequately treated carcinoma in situ or basal cell carcinoma of the skin).

-Chronic liver disease of a non-HCV etiology with the exception of steatosis (e.g., chronic hepatitis B, hemochromatosis, Wilson s disease, alfa-1 antitrypsin deficiency, cholangitis).

-Evidence of harmful or hazardous drinking as defined as a score >= 8 on the AUDIT questionnaire.

-Co-infection with HIV defined as the presence of anti-HIV in serum.

-Clinically relevant drug abuse based on patient history within 12 months of screening.

-Use of medications contraindicated with use of sofosbuvir/velpatasvir within 21 days of the Baseline/Day 1 visit; this washout period does not apply to proton pump inhibitors, which can be taken up to 7 days before baseline Day 1 for the following:

--Acid reducing Agents

--Antiarrhythmics

--Anticancer

--Antimycobacterial

--HIV antivirals

--Herbal supplements

--HMG-CoA Reductase Inhibitors

-Use of antiviral medications within the last 30 days.

-Chronic use of systemically administered immunosuppressive agents (e.g., prednisone equivalent >= 10 mg/day).

-Known hypersensitivity to sofosbuvir and velpatasvir, or formulation excipients.

-Hepatocellular carcinoma, or the presence of a mass on imaging studies of the liver that is suggestive of hepatocellular carcinoma, or an alpha-fetoprotein level of greater than 500 mg/mL

-Active psychiatric problems such as major depression, schizophrenia, bipolar illness, obsessive-compulsive disorder, severe anxiety, or personality disorder that, in the investigator s opinion, might interfere with participation in the study.

-Presence of conditions that, in the opinion of the investigators, would not allow the subject to n the current study for at least 1 year.

Phase II Follow-up

-Pregnancy

-Current or prior history of any of the following:

--Clinically significant illness (other than resolved HCV) or any other major medical disorder that may interfere with subject treatment, assessment, or compliance with the protocol; subjects currently under evaluation for a potentially clinically significant illness

(other than HCV) are also excluded

--Decompensated liver disease as defined by serum bilirubin >= 2.5 mg/dL (with direct

bilirubin >= 1.5 mg/dL), INR >1.5 a serum albumin of less than 3 g/dL, or a history of ascites, hepatorenal syndrome, variceal bleeding, or hepatic encephalopathy.

--Solid organ transplantation

--Significant pulmonary disease, significant cardiac disease

-History of malignancy or treatment for a malignancy within the past 3 years that is associated with a life expectancy <5 years (except adequately treated carcinoma in situ or basal cell carcinoma of the skin)

-Chronic liver disease with the exception of steatosis (e.g., chronic hepatitis B, hemochromatosis, Wilson s disease, alfa-1 antitrypsin deficiency, cholangitis)

-Evidence of harmful or hazardous drinking as defined as a score >= 8 on the AUDIT questionnaire

-Co-infection with HIV defined as the presence of anti-HIV in serum

-Clinically relevant drug abuse based on patient history within 12 months of screening

-Chronic use of systemically administered immunosuppressive agents (e.g., prednisone equivalent >= 10 mg/day)

-Hepatocellular carcinoma, or the presence of a mass on imaging studies of the liver that is suggestive of hepatocellular carcinoma, or an alpha-fetoprotein level of greater than 500 mg/mL

-Active psychiatric problems such as major depression, schizophrenia, bipolar illness, obsessive-compulsive disorder, severe anxiety, or personality disorder that, in the investigator s opinion, might interfere with participation in the study

-Presence of conditions that, in the opinion of the investigators, would not allow the patient to be followed in the current study for at least 1 year.


--Back to Top--

Citations:

Not Provided

--Back to Top--

Contacts:

Principal Investigator

Referral Contact

For more information:

Marc G. Ghany, M.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIHBC 10 - CLINICAL CENTER BG RM 10N248D
10 CENTER DR
BETHESDA MD 20892
(301) 402-5115
mg228m@nih.gov

Alaina Magnani
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institutes of Health
Building 10
Room 4-5744
10 Center Drive
Bethesda, Maryland 20892
(301) 451-6984
alaina.magnani@nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: TTY Users Dial 7-1-1
ccopr@nih.gov

Clinical Trials Number:

NCT03520660

--Back to Top--

NIH Clinical Center Search the Studies: Study Number, Study Title

Protocol Details

Long-Term Follow-Up Of Subjects With CHC Who Achieved A Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

18-DK-0091

Sponsoring Institute

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18 Years
Max Age: 120 Years

Referral Letter Required

No

Population Exclusion(s)

Pregnant Women;
Children

Keywords

Natural History;
Hepatitis C Virus;
Hepatocellular Carcinoma;
Fibrosis;
Immune Response

Recruitment Keyword(s)

None

Condition(s)

Diabetes Mellitus;
Hepatitis C, Chronic;
Cardiovascular Diseases

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

Drug: Epclusa

Supporting Site

National Institute of Diabetes and Digestive and Kidney Diseases

Background:

Chronic hepatitis C infects the liver. It may scar the liver. This is called cirrhosis and may lead to liver cancer or death. Current chronic hepatitis C treatments cure most people. But some keep getting complications even after it is cured. Researchers want to study why.

Objective:

To study the course and complications of liver disease after cure of hepatitis C infection.

Eligibility:

Adults 18 years and older infected with chronic hepatitis C virus who were never treated or were treated and not cured and those who were cured

Design:

Participants will be screened with:

Blood and urine tests

Questionnaires

Liver ultrasound

Fibroscan. A probe vibrates the liver, testing stiffness.

In Phase 1, people with chronic hepatitis C will:

Have a 3-day hospital admission to repeat some screening tests and have a liver biopsy. A small piece of liver is removed by needle passed through the skin.

Take 1 tablet containing 2 hepatitis C drugs once a day for 12 weeks.

Repeat some blood tests at 3 visits in those 12 weeks while on treatment, then 4 additional visits in the next 24 weeks with more blood work collected.

Phase 1 participants who test negative for hepatitis C and all other eligible participants will enter Phase 2.

Phase 2 participants will have a visit every 24 weeks for 10 years. These may include:

Repeats of screening tests

Questionnaires

Scans

Stool tests

Chest x-ray

Heart function test

Endoscopy. A tube guides a camera into the upper digestive system.

At about 5 years, participants will have another liver biopsy.

Some participants will give separate consent for genetic testing and a special blood procedure.

--Back to Top--

Eligibility

INCLUSION CRITERIA:

Phase I Treatment

-Male or female >= 18 years of age

-Either treatment naive or experienced defined as failure of a prior course of interferon-based and ribavirin, DAA plus interferon and DAA only

-Confirmation of chronic HCV infection documented by:

--A positive HCV RNA or positive HCV genotyping test at least 6-months prior to the Baseline/Day 1 visit

--A liver biopsy performed prior to screening visit showing evidence of chronic hepatitis.

-Subjects must have the following laboratory parameters at screening:

--ALT <= 10 x the upper limit of normal (ULN)

--AST <= 10 x ULN

--Total bilirubin <2.5 mg/dL, Direct bilirubin <= 1.5 ULN

--Platelets >= 50,000 K/mm3

--HbA1c <= 8.5%

--Hemoglobin >= 10g/dL

--Albumin >= 3g/dL

--INR <= 1.5 unless subject has known hemophilia or is stable on an anticoagulant regimen affecting INR.

--HCV RNA positive at screening.

-Subjects must be of generally good health, with the exception of chronic HCV infection, as determined by the Investigator.

Phase II Follow-up

-Male or female >= 18 years of age.

-SVR24 following therapy with a direct acting antiviral agent regimen and available liver biopsy performed prior to treatment.

-Subject must be of generally good health as determined by the Investigator.

EXCLUSION CRITERIA:

An individual who meets any of the following criteria will be excluded from participation in this study:

Phase I Treatment

-Pregnancy or lactation

-Inability to practice one form of adequate contraction for females of childbearing potential

-Prior treatment with a NS5a agent

-Current or prior history of any of the following:

--Clinically significant illness (other than HCV) or any other major medical disorder that may interfere with subject treatment, assessment, or compliance with the protocol; subjects currently under evaluation for a potentially clinically significant illness (other than HCV) are also excluded

--Gastrointestinal disorder or post-operative condition that could interfere with the absorption of the study drug

--Decompensated liver disease as defined by serum bilirubin >= 2.5 mg/dL (with direct bilirubin >= 1.5 mg/dL), INR >1.5 a serum albumin of less than 3 g/dL, or a history of ascites, hepatorenal syndrome, variceal bleeding, or hepatic encephalopathy

--Solid organ transplantation

--Significant pulmonary disease, significant cardiac disease

-History of malignancy or treatment for a malignancy within the past 3 years that is associated with a life expectancy <5 years (except adequately treated carcinoma in situ or basal cell carcinoma of the skin).

-Chronic liver disease of a non-HCV etiology with the exception of steatosis (e.g., chronic hepatitis B, hemochromatosis, Wilson s disease, alfa-1 antitrypsin deficiency, cholangitis).

-Evidence of harmful or hazardous drinking as defined as a score >= 8 on the AUDIT questionnaire.

-Co-infection with HIV defined as the presence of anti-HIV in serum.

-Clinically relevant drug abuse based on patient history within 12 months of screening.

-Use of medications contraindicated with use of sofosbuvir/velpatasvir within 21 days of the Baseline/Day 1 visit; this washout period does not apply to proton pump inhibitors, which can be taken up to 7 days before baseline Day 1 for the following:

--Acid reducing Agents

--Antiarrhythmics

--Anticancer

--Antimycobacterial

--HIV antivirals

--Herbal supplements

--HMG-CoA Reductase Inhibitors

-Use of antiviral medications within the last 30 days.

-Chronic use of systemically administered immunosuppressive agents (e.g., prednisone equivalent >= 10 mg/day).

-Known hypersensitivity to sofosbuvir and velpatasvir, or formulation excipients.

-Hepatocellular carcinoma, or the presence of a mass on imaging studies of the liver that is suggestive of hepatocellular carcinoma, or an alpha-fetoprotein level of greater than 500 mg/mL

-Active psychiatric problems such as major depression, schizophrenia, bipolar illness, obsessive-compulsive disorder, severe anxiety, or personality disorder that, in the investigator s opinion, might interfere with participation in the study.

-Presence of conditions that, in the opinion of the investigators, would not allow the subject to n the current study for at least 1 year.

Phase II Follow-up

-Pregnancy

-Current or prior history of any of the following:

--Clinically significant illness (other than resolved HCV) or any other major medical disorder that may interfere with subject treatment, assessment, or compliance with the protocol; subjects currently under evaluation for a potentially clinically significant illness

(other than HCV) are also excluded

--Decompensated liver disease as defined by serum bilirubin >= 2.5 mg/dL (with direct

bilirubin >= 1.5 mg/dL), INR >1.5 a serum albumin of less than 3 g/dL, or a history of ascites, hepatorenal syndrome, variceal bleeding, or hepatic encephalopathy.

--Solid organ transplantation

--Significant pulmonary disease, significant cardiac disease

-History of malignancy or treatment for a malignancy within the past 3 years that is associated with a life expectancy <5 years (except adequately treated carcinoma in situ or basal cell carcinoma of the skin)

-Chronic liver disease with the exception of steatosis (e.g., chronic hepatitis B, hemochromatosis, Wilson s disease, alfa-1 antitrypsin deficiency, cholangitis)

-Evidence of harmful or hazardous drinking as defined as a score >= 8 on the AUDIT questionnaire

-Co-infection with HIV defined as the presence of anti-HIV in serum

-Clinically relevant drug abuse based on patient history within 12 months of screening

-Chronic use of systemically administered immunosuppressive agents (e.g., prednisone equivalent >= 10 mg/day)

-Hepatocellular carcinoma, or the presence of a mass on imaging studies of the liver that is suggestive of hepatocellular carcinoma, or an alpha-fetoprotein level of greater than 500 mg/mL

-Active psychiatric problems such as major depression, schizophrenia, bipolar illness, obsessive-compulsive disorder, severe anxiety, or personality disorder that, in the investigator s opinion, might interfere with participation in the study

-Presence of conditions that, in the opinion of the investigators, would not allow the patient to be followed in the current study for at least 1 year.


--Back to Top--

Citations:

Not Provided

--Back to Top--

Contacts:

Principal Investigator

Referral Contact

For more information:

Marc G. Ghany, M.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIHBC 10 - CLINICAL CENTER BG RM 10N248D
10 CENTER DR
BETHESDA MD 20892
(301) 402-5115
mg228m@nih.gov

Alaina Magnani
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institutes of Health
Building 10
Room 4-5744
10 Center Drive
Bethesda, Maryland 20892
(301) 451-6984
alaina.magnani@nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: TTY Users Dial 7-1-1
ccopr@nih.gov

Clinical Trials Number:

NCT03520660

--Back to Top--