Efficacy of Peginterferon Alfa-2b in Previously Untreated Subjects With Chronic Hepatitis B and D Co-infection (Study P04603)

NCT00686790 | Completed Phase 3 Results

• 1 other identifier: P04603
• Study Type: interventional
• Target: 68
• Locations: 0 countries
• Sites: N/A

Brief Summary

The objective of this study is to determine the effectiveness of peginterferon alfa-2b 1.5 mcg/kg/week administered for 52 weeks (wk) in previously untreated participants coinfected with hepatitis virus B and D. After 52-week treatment and 52-week follow-up, the virologic, biochemical, and histological response will be evaluated.

Conditions

Hepatitis D, Chronic; Hepatitis B, Chronic

Keywords

Hepatitis D; Hepatitis B

Outcome Measures

Primary Outcomes (3)

• Number of Participants With a Virological Response

  For virological response, a participant was defined as a responder if his/her serum sample tested negative for Hepatitis D Virus - ribonucleic acid (HDV-RNA) by polymerase chain reaction (PCR) at end of treatment (EOT).

  52 weeks (end of treatment [EOT]), 104 weeks (end of follow-up [EOF]) following treatment initiation

• Number of Participants With a Biochemical Response

  A participant was defined as a responder if his alanine aminotransferase (ALT) level after 52 weeks, i.e. at EOT, was below the upper reference range as specified by Bioclinica. The normal reference range for ALT is 5-55 U/L.

  52 weeks (EOT), 104 weeks (EOF)

• Number of Participants With a Combined Response

  The combined response was defined as an ALT level below the upper reference range and a negative HDV-RNA test. The normal reference range for ALT is 5-55 U/L.

  52 weeks (EOT), 104 weeks (EOF)

Secondary Outcomes (2)

• Number of Participants With Hepatitis B Virus (HBV) Replication Response (HBV Response)

  52 week (EOT)

• Number of Participants With a Liver Histology Response

  Baseline and 52 week (EOT)

Study Arms (1)

PegIntron

EXPERIMENTAL

All participants received PegIntron (Peginterferon alfa-2b) weekly based on their body weight.

Biological: Peginterferon alfa-2b (PegIntron, SCH 54031)

Interventions

Peginterferon alfa-2b (PegIntron, SCH 54031) BIOLOGICAL

Peginterferon alfa-2b 1.5 mcg/kg/wk subcutaneously (SC) for 52 weeks.

Also known as: SCH 54031, PegIntron

PegIntron

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must demonstrate their willingness to participate in the study and comply with its procedures by signing a written informed consent.
• Age 18-65 years old.
• HBsAg positive \>6 months.
• ALT \>= 2 ULN \>6 months.
• HDV RNA positive serology.
• Serum antibody to hepatitis delta antigen of IgG and IgM class.
• Knodell score HAI \>= 6 and F \>= 0; positive test for intrahepatic Delta antigen in liver biopsy.
• Women of childbearing potential (includes women who are less than 1 year postmenopausal and women who become sexually active) must be using an acceptable method of birth control (e.g., hormonal contraceptive, medically prescribed IUD, condom in combination with spermicide) or be surgically sterilized (e.g., hysterectomy or tubal ligation).
• Participants must be free of any clinically significant disease (other than chronic hepatitis B and D), that would interfere with study evaluations.
• Participants must understand and be able to adhere to the dosing and visit schedules, and agree to record symptom severity scores, medication times, concomitant medications, and adverse events accurately and consistently in a daily diary.

You may not qualify if:

• Age \<18 and \>65.
• Concomitant HCV and/or HIV infection.
• Actual liver failure (total serum bilirubin \>2.5 x normal, prolonged prothrombin time \>3 sec, serum albumin \<3 g/dl, history of ascites, variceal bleeding, or hepatic encephalopathy).
• Toxic or autoimmune hepatitis (ANA titers \> 1:160), metabolic liver diseases (Wilson disease, hemochromatosis, α-1 antitrypsin deficiency)
• Women who are pregnant or nursing.
• Leukopenia (\<2500/mm\^3), neutropenia (\<1000/mm\^3), hemoglobin \<10 g/dl, presence of other severe diseases (myocardiopathy, diabetes mellitus, arterial hypertension, neoplasia, neurologic diseases, malnutrition).
• Antiviral, immunomodulatory, corticosteroid, or chemotherapeutical treatment within 6 months of the participation in the study.
• Depression and/or psychiatric disorders.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Hepatitis D, Chronic; Hepatitis B, Chronic; Hepatitis D; Hepatitis B

Interventions

peginterferon alfa-2b

Condition Hierarchy (Ancestors)

Hepatitis, Viral, Human; Virus Diseases; Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Blood-Borne Infections; Communicable Diseases; Hepadnaviridae Infections; DNA Virus Infections

Results Point of Contact

• Title: Vice President of Late Stage Development
• Organization: Merck Sharp & Dohme Corp

ClinicalTrialsDisclosure@merck.com

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2008
• First Posted: May 30, 2008
• Study Start: December 1, 2005
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2009
• Last Updated: April 6, 2017
• Results First Posted: January 17, 2011

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will share