Evaluation of Peginterferon Alfa-2b Monotherapy and Combination With Ribavirin in Participants With Acute Hepatitis C (P03552/MK-4031-137)

NCT00686517 | Completed Phase 3 Results

• 1 other identifier: P03552
• Study Type: interventional
• Target: 130
• Locations: 0 countries
• Sites: N/A

Brief Summary

The objective of this study is to evaluate the efficacy of three regimens of pegylated interferon-alfa 2b (PEG-IFN) either as monotherapy or in combination with ribavirin in participants with acute hepatitis C. After 12 weeks of observation from disease onset, participants will receive one of the following regimens: (1) a 24-week course of PEG-IFN monotherapy (PEG-IFN 24); or (2) a 12-week course of PEG-IFN monotherapy (PEG-IFN-12); or (3) a 12-week course of PEG-IFN in combination with ribavirin (PEG-IFN + RVB 12). After the treatment period, participants will enter a 12-month follow-up.

Conditions

Hepatitis C

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Sustained Response (SR) at the End of the 6-month Follow-up Period

  SR was defined as serum Hepatitis C Virus (HCV RNA) level at the end of 6-month follow-up below 15 IU/mL.

  Evaluated at the end of 6 months

Secondary Outcomes (5)

• Virologic Response at the End of Treatment Follow-up (ETR)

  At the end of treatment (either 12 weeks or 24 weeks depending on randomization).

• Virologic Response at 12 Months Post-treatment Follow-up (Long-term Response, [LTR]).

  At 12 months post-treatment (treatment period either 12 weeks or 24 weeks depending on randomization).

• Number of Participants Presenting With Alanine Transferase (ALT) Level Normalization

  Evaluated at end of treatment (either 12 weeks or 24 weeks, depending on randomization), at 6-month follow-up visit, or at 12-month follow-up visit.

• Number of Participants With Rapid Virologic Response (RVR)

  Evaluated at 2 and 4 weeks of treatment

• Number of Peripheral Blood Mononuclear Cells (PBMCs)

  Treatment Weeks 2, 4, 8, and 12

Study Arms (3)

PEG-IFN 24

EXPERIMENTAL

pegylated interferon alpha-2b 1.5 ug/kg/week for 24 weeks

Biological: Pegylated interferon alfa-2b

PEG-IFN 12

EXPERIMENTAL

pegylated interferon alpha-2b 1.5 ug/kg/week for 12 weeks

Biological: Pegylated interferon alfa-2b

PEG-IFN + RVB 12

EXPERIMENTAL

pegylated interferon alpha-2b 1.5 ug/kg/week in combination with ribavirin at the dose of 10.6 mg/kg/day for 12 weeks

Biological: Pegylated interferon alfa-2b; Drug: Ribavirin

Interventions

Pegylated interferon alfa-2b BIOLOGICAL

1.5 ug/kg/week SC for 12 or 24 weeks

Also known as: SCH 54031, PegIntron

PEG-IFN + RVB 12; PEG-IFN 12; PEG-IFN 24

Ribavirin DRUG

Ribavirin at the dose of 10.6 mg/kg/day for 12 weeks

Also known as: SCH 18908, Rebetol

PEG-IFN + RVB 12

Eligibility Criteria

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

You may qualify if:

• Diagnosed with acute hepatitis C virus (HCV).
• Normal and Elevated serum alanine transferase (ALT) levels
• Positive serum HCV-RNA.
• Aged between 18 and 65 years.
• Negative urine or serum pregnancy test (for women of childbearing potential) documented within the 24-hour period prior to the first dose of the drug. Additionally, all fertile males with partners of childbearing age and females must be using reliable contraception during the study and additionally for participants treated with ribavirin, for 6 months (for woman) and 7 months (for man and his partner) after treatment completion

You may not qualify if:

• Liver disease unrelated to HCV infection
• Hemoglobin (Hgb) \<12g/dL in women and \<13g/dL in men; white blood cells (WBC) \<3,000/uL; platelets (PLTs) \<100,000/ul
• Women with ongoing pregnancy or who are breast feeding
• History of severe psychiatric disease, especially depression
• History of neurologic disease, especially epilepsy
• History or evidence of symptoms of severe cardiac, gastrointestinal and kidney disease
• Positive anti-Human Immunodeficiency Virus (HIV) antibodies
• Positive anti-nuclear antibodies (ANA) and/or Anti-Smooth Muscle Antibody (ASMA) (\>1/80)
• Positive Hepatitis B surface antigen (HBsAg)
• History of having received any systemic anti-neoplastic or immunomodulatory treatment in the previous 6 months
• History or other evidence of severe illness or any other conditions which would make the participants, in the opinion of investigator, unsuitable for the study (active drug addict except those under methadone treatment, thalassemic, dyalized included)

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead
• Bioikos Ambiente Srl: collaborator

Related Publications (1)

• Santantonio T, Fasano M, Sagnelli E, Tundo P, Babudieri S, Fabris P, Toti M, Di Perri G, Marino N, Pizzigallo E, Angarano G; Acute Hepatitis C Study Group. Acute hepatitis C: a 24-week course of pegylated interferon alpha-2b versus a 12-week course of pegylated interferon alpha-2b alone or with ribavirin. Hepatology. 2014 Jun;59(6):2101-9. doi: 10.1002/hep.26991. Epub 2014 Apr 29.

  PMID: 24442928 RESULT

MeSH Terms

Conditions

Hepatitis C

Interventions

peginterferon alfa-2b; Ribavirin

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Results Point of Contact

• Title: Senior Vice President, Global Clinical 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: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2008
• First Posted: May 30, 2008
• Study Start: December 1, 2003
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: April 5, 2017
• Results First Posted: January 31, 2012

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will share