CClinicalTrials.gg
Sign In
CompletedNCT00787371Updated Mar 13, 2017

Effect of Low-dose PegIntron on ALT Normalization in Japanese Patients With Chronic Hepatitis C (Study P04508)(COMPLETED)

A Phase 2 interventional study of PegIntron (peginterferon alfa-2b) and PegIntron (peginterferon alfa-2b) in Hepatitis C, Chronic and Hepatitis C, sponsored by Merck Sharp & Dohme LLC. Completed. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2017-03-13.

Sponsored by Merck Sharp & Dohme LLC · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
69
Allocation
Randomized
Ages
20 Years and older
Sex
All
01

Study summary

In patients with chronic hepatitis C, the ultimate treatment goal is the improvement of liver histology and inhibition of progression to liver cirrhosis and hepatocellular carcinoma (HCC). These effects are reported to be correlated with sustained ALT improvement. Therefore, the aim of this study is to determine if a low-dose (0.25, 0.5, or 1.0 mcg/kg SC QW) PegIntron monotherapy administered for 12 weeks will result in ALT normalization in Japanese patients with chronic hepatitis C.

02

Conditions studied

  • Hepatitis C, Chronic
  • Hepatitis C

Keywords

  • alanine transaminase
03

In context

Hepatitis A

2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.

This study's enrollment of 69 is below the median of 100 across 1,886 interventional studies indexed under Hepatitis A.

Browse Hepatitis A studies →

Lead sponsor

Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 133 are open to participants now.

Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

Patients with chronic hepatitis C patients (CHC) who met all of the following criteria:

  • At least 20 years of age and willing to sign an informed consent
  • Patients who can practice contraception
  • Patients who are classified either as relapsers or non-responders.
  • Weight between 45 and 100 kg
  • Patients willing to be hospitalized for 3 days after the start of treatment
  • Patients with positive HCV-RNA
  • Serum ALT level: Over 60 IU/L, equal to or less than 150 IU/L
  • Neutrophil count: equal to or more than 1,200 /mm\^3
  • Platelet count：equal to or more than 100,000/mm\^3

Exclusion criteria

Exclusion Criteria:

  • Patients with conditions which would interfere with the evaluation of therapeutic efficacy of the study drug and patients for whom assurance of safety is a concern were excluded from the study.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
69 participants (actual)

Study arms

  • Experimental
    0.25 Dose Group

    PegIntron 0.25 mcg/kg SC QW for 12 weeks

    Biological: PegIntron (peginterferon alfa-2b)

  • Experimental
    0.5 Dose Group

    PegIntron 0.5 mcg/kg SC QW for 12 weeks

    Biological: PegIntron (peginterferon alfa-2b)

  • Experimental
    1.0 Dose Group

    PegIntron 1.0 mcg/kg SC QW for 12 weeks

    Biological: PegIntron (peginterferon alfa-2b)

  • No intervention
    No-treatment Control

    No treatment (no placebo)

Interventions

  • BiologicalPegIntron (peginterferon alfa-2b)

    PegIntron 0.25 mcg/kg subcutaneously (SC) once a week (QW) for 12 weeks

    Also known as: PegIntron, peginterferon alfa-2b, SCH 54031

  • BiologicalPegIntron (peginterferon alfa-2b)

    PegIntron 0.5 mcg/kg SC QW for 12 weeks

    Also known as: PegIntron, peginterferon alfa-2b, SCH 54031

  • BiologicalPegIntron (peginterferon alfa-2b)

    PegIntron 1.0 mcg/kg subcutaneously (SC) once a week (QW) for 12 weeks

    Also known as: PegIntron, peginterferon alfa-2b, SCH 54031

06

What researchers measure

Primary outcomes

  1. Percentage of patients who achieve normalization of ALT in each treatment group

    Time frame: Measured at the end of 12 weeks of treatment or at discontinuation.

Secondary outcomes

  1. Safety: adverse events, adverse reactions, laboratory test result (hematology, blood biochemistry and thyroid function test)

    Time frame: Measured between when the patient signs the informed consent form and the end of post-treatment follow-up

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 13, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00787371
Lead sponsor
Merck Sharp & Dohme LLC
Responsible party
Sponsor
First posted
Nov 7, 2008
Start date
Jun 2005
Primary completion
Jul 2006
Completion
Jul 2006
Last update
Mar 13, 2017

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Hepatitis A→

Other studies from this sponsor

Merck Sharp & Dohme LLC

Start the discussion