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)
This study is not yet open for participant recruitment.
Verified March 2013 by Merck
Sponsor:
Merck
Information provided by (Responsible Party):
Merck
ClinicalTrials.gov Identifier:
NCT01727271
First received: November 12, 2012
Last updated: March 8, 2013
Last verified: March 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Hepatitis B |
Drug: Tenofovir Biological: Pegylated interferon alpha-2b |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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. |
Resource links provided by NLM:
Drug Information available for:
Interferon
Interferon Alfa-2a
Interferon Alfa-2b
Tenofovir
Tenofovir Disoproxil Fumarate
Peginterferon Alfa-2b
Truvada
U.S. FDA Resources
Further study details as provided by Merck:
Primary Outcome Measures:
- Number of participants who responded to treatment [ Time Frame: Week 128 ] [ Designated as safety issue: No ]
- Number of participants experiencing adverse events (AEs) [ Time Frame: Up to 128 weeks ] [ Designated as safety issue: Yes ]
- Number of participants discontinuing study therapy due to AEs [ Time Frame: Up to 104 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 150 |
| Study Start Date: | August 2013 |
| Estimated Study Completion Date: | August 2017 |
| Estimated Primary Completion Date: | August 2017 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Tenofovir Monotherapy
Tenofovir 300 mg tablet, orally (PO) once daily for 8 weeks, then Tenofovir 300 mg tablet, PO, once daily for an additional 96 weeks (total treatment duration 104 weeks)
|
Drug: Tenofovir
Other Name: Truvada
|
|
Experimental: PegIFN-2b/Tenofovir Sequential Therapy
Tenofovir 300 mg tablet, PO, once daily for 8 weeks, then PegIFN-2b, 1.5 mcg/kg subcutaneously (SC), once weekly, for 24 weeks, then Tenofovir 300 mg tablet, PO, once daily for 72 weeks (total treatment duration 104 weeks)
|
Drug: Tenofovir
Other Name: Truvada
Biological: Pegylated interferon alpha-2b
Other Names:
|
|
Experimental: Peg-IFN-2b + Tenofovir Combination Therapy
Tenofovir 300 mg tablet, PO once daily for 8 weeks, then pegIFN-2b, 1.5 mcg/kg SC once weekly and tenofovir 300 mg tablet, PO, once daily for 24 weeks, and then tenofovir 300 mg tablet, PO, once daily for 72 weeks (total treatment duration 104 weeks)
|
Drug: Tenofovir
Other Name: Truvada
Biological: Pegylated interferon alpha-2b
Other Names:
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
No Contacts or Locations Provided
More Information
No publications provided
| Responsible Party: | Merck |
| ClinicalTrials.gov Identifier: | NCT01727271 History of Changes |
| Other Study ID Numbers: | 4031-384 |
| Study First Received: | November 12, 2012 |
| Last Updated: | March 8, 2013 |
| Health Authority: | India: Institutional Review Board |
Additional relevant MeSH terms:
|
Hepatitis Hepatitis A Hepatitis B Hepatitis, Chronic Hepatitis B, Chronic Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections Hepadnaviridae Infections DNA Virus Infections Interferon-alpha |
Interferon Alfa-2a Interferon Alfa-2b Interferons Tenofovir Tenofovir disoproxil Peginterferon alfa-2b Reaferon Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Immunologic Factors Physiological Effects of Drugs Angiogenesis Inhibitors Angiogenesis Modulating Agents |
ClinicalTrials.gov processed this record on May 21, 2013