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Protocol Details

Combination Therapy of Pegylated Interferon Alfa-2a and Tenofovir DF versus Tenofovir DF Monotherapy in HBeAg-Positive and HBeAg-Negative Chronic Hepatitis B

This study is NOT currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

13-DK-0091

Sponsoring Institute

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

Recruitment Detail

Type: Completed Study; data analyses ongoing
Gender: Male & Female
Min Age: 18
Max Age: N/A

Referral Letter Required

No

Population Exclusion(s)

Children

Special Instructions

Currently Not Provided

Keywords

Hepatitis B;
Anti-Viral Treatment;
Pegylated Interferon;
Tenofovir Disoproxil Fumarate;
Hepatitis B Surface Antigen

Recruitment Keyword(s)

None

Condition(s)

Chronic Hepatitis B e Antigen Negative;
Chronic Hepatitis B e Antigen Positive

Investigational Drug(s)

Peginterferon
Tenofovir DF

Investigational Device(s)

None

Intervention(s)

Drug: Peginterferon alfa-2a
Drug: Tenofovir DF

Supporting Site

National Institute of Diabetes and Digestive and Kidney Diseases

Background:

- There are two forms of chronic hepatitis B. The difference between the forms is whether or not a viral protein called hepatitis B e antigen is present in the blood. Standard approaches to treating both forms of chronic hepatitis B involve different drugs. One drug is called peginterferon, another is called tenofovir DF. These drugs are often given separately and used for different forms of the disease. However, researchers want to see if combining peginterferon and tenofovir DF will be a more effective treatment than tenofovir DF alone.

Objectives:

- To see whether combining tenofovir DF and peginterferon, or using tenofovir DF alone, is a more effective treatment of chronic hepatitis B.

Eligibility:

- Individuals at least 18 years of age who have chronic hepatitis B and are in the Hepatitis B Research Network Cohort study.

Design:

- Participants will be screened with a physical exam and medical history. Blood, urine, and liver tissue samples will be collected. Bone and liver imaging studies will also be performed.

- Participants will be divided into two groups. One group will have tenofovir DF alone for 192 weeks (about 4 years). The other group will have tenofovir DF and peginterferon for 24 weeks (about 6 months), and then tenofovir DF alone for 168 weeks (about 3.5 years).

- Participants will take the study drugs on the schedule determined by their study doctors. They will keep a diary to record their doses and any side effects.

- Participants will have three study visits 4 weeks apart after the starting the treatment. At these visits, they will have a physical exam and provide blood samples. They may also provide urine samples and have imaging studies.

- After the first three study visits, participants will continue to have study visits every 12 weeks until the treatment ends at week 192. These visits will have many of the same tests as the first three visits. At some of these visits, they may fill out questionnaires about their quality of life.

- Participants who do not respond to the study drugs may have their medications changed. They may also be asked to stop treatment.

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Eligibility

For the study of the effects of pregnancy on hepatitis B infection two sources of participants are anticipated:

1. Women of childbearing age already enrolled who become pregnant.

2. Pregnant women infected with hepatitis B who are referred to a hepatologist at a HBRN recruitment site and consent to enroll in this study.

INCLUSION CRITERIA:

-Written informed consent

-At least 18 years of age

-HBsAg-positive and either:

--Pregnant

--Anti-HDV positive

--Diagnosed with acute HBV infection or are experiencing a hepatitis

flare

--Phenotype of immune tolerant or immune active

--Potentially eligible for the Immune Regulation and Costimulation in Natural History of Chronic Hepatitis B ancillary study.

OR

completed the HBRN Adult Immune Active trial (regardless of HBsAg status)

EXCLUSION CRITERIA:

-History of hepatic decompensation

-Hepatocellular carcinoma (HCC)

-History of solid organ transplantation or bone marrow transplantation

-Chronic immunosuppression therapy

-Current hepatitis B antiviral treatment (except pregnant women, patients who are anti HDV positive, and participants who completed the HBRN Adult Immune Active trial)

-Known HIV co-infection (patients with HDV or HCV co-infection are not excluded).

-Medical or social condition which, in the opinion of the investigator, would make the patient unsuitable for the study or interfere with or prevent follow-up per protocol

-Unable or unwilling to return for follow-up visits


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

Marc G. Ghany, M.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
BG 10 RM 10N248D
10 CENTER DR
BETHESDA MD 20814
(301) 402-5115
mg228m@nih.gov

Elenita Rivera, R.N.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institutes of Health
Building 10
Room 8E
10 Center Drive
Bethesda, Maryland 20892
(301) 435-6125
erivera@cc.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:

NCT01369212

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