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: N/A

Referral Letter Required

No

Population Exclusion(s)

Pregnant Women and Fetuses;
Children

Special Instructions

Currently Not Provided

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 (except for NS5a failures)

-Confirmation of chronic HCV infection documented by either:

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

--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

-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, or porphyria

-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 any prohibited concomitant medications 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, or porphyria

-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)



Steffan L. Cooper
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institutes of Health
Building 10
Room 4-5722
10 Center Drive
Bethesda, Maryland 20892
(301) 451-6984
steffan.cooper@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: 1-866-411-1010
PRPL@cc.nih.gov

Clinical Trials Number:

NCT03520660

--Back to Top--