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Completed

NCT Number: NCT00686517

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

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.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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)

Treatment and study plan

Pegylated interferon alfa-2b

Biological

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

Other names: SCH 54031, PegIntron

Ribavirin

Drug

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

Other names: SCH 18908, Rebetol

Primary outcomes

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

    Time frame: Evaluated at the end of 6 months

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

Secondary outcomes

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

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

    ETR was achieved if serum HCV RNA level at the end of 12 or 24 weeks

    treatment (depending on treatment arm) was <15 IU/mL.

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

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

    LTR was obtained if serum HCV RNA level at the end of 12-month follow-up was <15 IU/mL.

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

    Time frame: 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.

    ALT normalization was used as a measure of biochemical response to treatment. ALT levels were assessed at each study visit by the local laboratory, and efficacy measurements at the end of treatment, at 6 and 12 months post treatment follow-up were reported.

  4. Number of Participants With Rapid Virologic Response (RVR)

    Time frame: Evaluated at 2 and 4 weeks of treatment

    Participants were considered to have RVR if serum HCV RNA level at 2 or 4

    weeks of treatment was below the cut off value of the referring local

    laboratory of each participating site.

  5. Number of Peripheral Blood Mononuclear Cells (PBMCs)

    Time frame: Treatment Weeks 2, 4, 8, and 12

    Cellular Differentiation Cluster Antigen 8-Positive (CD8+) PBMCs were measured at randomization, Treatment Weeks 2, 4, 8, and 12.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Collaborators

  • Bioikos Ambiente Srl

Registry information

Official study title

An Open, Randomized, Multicentre Trial to Evaluate Efficacy and Safety of a 24-week Course of PEG-Interferon Alpha-2b Versus a 12-week Course of PEG-Interferon Alpha-2b Alone or Plus Ribavirin in Patients With Acute Hepatitis C

Important dates

Study start
2003
Primary completion
2010
Study completion
2010
First posted
May 30, 2008
Registry last updated
Apr 5, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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