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)

Hepatitis B Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01727271
• Other study ID #: 4031-384
• Status: Withdrawn
• Phase: Phase 4
• First received: November 12, 2012
• Last updated: September 18, 2013
• Start date: August 2013
• Est. completion date: August 2017

Study information

• Verified date: September 2013
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• Tenofovir

Biological:
• Pegylated interferon alpha-2b

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants who responded to treatment		Week 128	No
Primary	Number of participants experiencing adverse events (AEs)		Up to 128 weeks	Yes
Primary	Number of participants discontinuing study therapy due to AEs		Up to 104 weeks	No