A Study to Compare Efficacy and Safety of Tenofovir Used Alone or in Combination With Pegylated Interferon Alpha-2b in Participants With Chronic Hepatitis B and Elevated Alanine Aminotransferase (MK-4031-384)

An Open-Label, Pilot, Randomized, Multi-Center Study to Compare Efficacy and Safety of Tenofovir Monotherapy Alone With Tenofovir Monotherapy Followed by Concurrent Combination of Pegylated Interferon-Alpha-2b and Tenofovir or Tenofovir Monotherapy Followed by Sequential Therapy of Pegylated Interferon-Alpha-2b and Tenofovir in HBeAG-Positive Chronic Hepatitis B Patients With Raised ALT.

Status

Withdrawn

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01727271

Enrollment

Registered

2012-11-15

Start date

2013-08-31

Completion date

2017-08-31

Last updated

2013-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis B

Brief summary

This study will compare monotherapy with tenofovir to sequential therapy with pegylated interferon alpha-2b (pegIFN-2b) followed by tenofovir, and to combination therapy with pegIFN-2b + tenofovir, in participants with hepatitis B e antigen (HBeAg)-positive chronic hepatitis B and elevated alanine aminotransferase (ALT). All enrolled participants will be be administered tenofovir alone for 8 weeks and then will be randomly assigned to 1 of the 3 treatment arms.

Interventions

DRUGTenofovir

BIOLOGICALPegylated interferon alpha-2b

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Chronic hepatitis B (hepatitis B surface antigen \[HBsAg\]-positive for \>6 months or evidence of chronic hepatitis B in liver biopsy) * Elevated serum ALT level * Liver biopsy or a non-invasive investigation within 12 months prior to randomization with Chronic Hepatitis B * Treatment naïve or history of interferon for not more than 1 month, taken at least 6 months before enrollment * Compensated liver disease

Exclusion criteria

* Known hypersensitivity to tenofovir, interferon alpha-2b, and/or any other component of the study products * Co-infection with hepatitis C virus (HCV), hepatitis D virus (HDV) or human immunodeficiency virus (HIV) * Need for prolonged or frequent use of systemic acyclovir or famciclovir * Previously received lamivudine or an investigational anti-hepatitis B virus (HBV) nucleoside or nucleotide analog and were resistant to these drugs * History of variceal bleeding or other GI bleeding due to portal hypertension, hepatic encephalopathy, spontaneous bacterial peritonitis, Grade III and IV esophageal varices unless banded or other clinical signs of hepatic decompensation * History of hepatocellular carcinoma (HCC) or findings suggestive of possible HCC * Need for potentially hepatotoxic drugs (e.g. dapsone, erythromycin, fluconazole, ketoconazole, rifampin, and anti-tuberculosis regimens) or nephrotoxic drugs (e.g. frequent nonsteroidal anti-inflammatories, aminoglycosides, amphotericin B, and foscarnet) * One or more additional known primary or secondary causes of liver disease, other than hepatitis B * History of clinical pancreatitis * Pregnant or breastfeeding * Female participants of childbearing potential and male participants must be willing to use acceptable method of birth control. * Medical condition that requires frequent or prolonged use of systemic corticosteroids * Use of warfarin or other anticoagulants during 30 days prior to screening or if expected to be needed during the study period

Design outcomes

Primary

Measure	Time frame
Number of participants who responded to treatment	Week 128
Number of participants experiencing adverse events (AEs)	Up to 128 weeks
Number of participants discontinuing study therapy due to AEs	Up to 104 weeks

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026