Prevention of Disease Progress in Chronic Hepatitis C Patients With Liver Fibrosis (Study P02570AM2)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00049842
First received: November 14, 2002
Last updated: April 25, 2014
Last verified: April 2014
  Purpose

The objective of the study is to evaluate the safety and efficacy of PEG-Intron versus no treatment for the prevention of fibrosis progression in adult participants with moderate to severe liver fibrosis secondary to chronic hepatitis C, who failed PEG-Intron plus Rebetol treatment in protocol P02370 (NCT00039871).


Condition Intervention Phase
Chronic Hepatitis C
Liver Fibrosis
Biological: peginterferon alfa-2b (SCH 54031)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: PEG-Intron(TM) Maintenance Therapy vs. an Untreated Control Group for Prevention of Progression of Fibrosis in Adult Subjects With Chronic Hepatitis C With Hepatic Fibrosis (METAVIR Fibrosis Score of F2 or F3), Who Failed Therapy With PEG-Intron Plus REBETOL(R) (in Protocol No. P02370)

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Fibrosis Response Status (ie, Improvement, no Change, or the Worsening of the Fibrosis Score in Participants With Baseline METAVIR Fibrosis Score of F2 or F3). [ Time Frame: Baseline to up to Month-36 ] [ Designated as safety issue: No ]

    Definitions:

    Fibrosis scoring: F0 (no fibrosis), F1 (stellate enlargement of portal tract without septa formation, F2 (enlargement of portal tract with rare septa formation, F3 (numerous septa without cirrhosis), F4 (cirrhosis).

    Improved: Participants whose METAVIR fibrosis score at up to Month-36 decreases by 1 or more units compared to baseline.

    No Change: Participants whose METAVIR fibrosis score at up to Month-36 is the same as the baseline score.

    Worsened: Participants whose METAVIR fibrosis score at up to Month-36 increases by 1 or more units compared to baseline.



Secondary Outcome Measures:
  • Inflammation Response Status (ie, Improvement, no Change, or the Worsening of the METAVIR Activity Score as Compared to Baseline) [ Time Frame: Baseline to up to Month-36 ] [ Designated as safety issue: No ]

    Activity Scoring: A0 (no histological activity), A1 (minimal activity), A2 (moderate activity), A3 (severe activity), A4 (lobular chronic hepatitis).

    Changes in liver inflammation defined as follows:

    Improved: Participants whose METAVIR activity score at up to Month-36 decreases by 1 or more units compared to baseline.

    No Change: Participants whose METAVIR activity score at up to Month-36 is the same as the baseline score.

    Worsened: Participants whose METAVIR activity score at up to Month-36 increases by 1 or more units compared to baseline.


  • Mean Change From Baseline to up to Month-36 in the METAVIR Fibrosis Score (Using a Continuous Scale) [ Time Frame: Baseline to up to Month-36 ] [ Designated as safety issue: No ]

    The change of Metavir Fibrosis Score = Metavir Fibrosis Score at up to Month-36 - Metavir Fibrosis Score at Baseline.

    Fibrosis scoring: 0 (no fibrosis), 1 (stellate enlargement of portal tract without septa formation, 2 (enlargement of portal tract with rare septa formation, 3 (numerous septa without cirrhosis), 4 (cirrhosis).


  • The Number of Participants Whose METAVIR Fibrosis Score Did Not Worsen (ie, the Response Status of Improved/no Change) During Treatment Compared to Baseline [ Time Frame: Baseline to up to Month-36 ] [ Designated as safety issue: No ]

    Definitions:

    Fibrosis scoring: F0 (no fibrosis), F1 (stellate enlargement of portal tract without septa formation, F2 (enlargement of portal tract with rare septa formation, F3 (numerous septa without cirrhosis), F4 (cirrhosis).

    Improved: Participants whose METAVIR fibrosis score at up to Month-36 decreases by 1 or more units compared to baseline.

    No Change: Participants whose METAVIR fibrosis score at up to Month-36 is the same as the baseline score.

    Worsened: Participants whose METAVIR fibrosis score at up to Month-36 increases by 1 or more units compared to baseline.


  • Mean Change in the METAVIR Activity Score (Using a Continuous Scale) [ Time Frame: Baseline to up to Month-36 ] [ Designated as safety issue: No ]

    The change of Metavir Activity Score = Metavir Activity Score at up to Month-36 - Metavir Activity Score at Baseline.

    Activity Scoring: 0 (no histological activity), 1 (minimal activity), 2 (moderate activity), 3 (severe activity), 4 (lobular chronic hepatitis).


  • Number of Participants With no Worsening (ie, the Response Status of Improved/ no Change) in the METAVIR Activity Score During the Treatment. [ Time Frame: Baseline to up to Month-36 ] [ Designated as safety issue: No ]

    Definitions:

    Activity Scoring: A0 (no histological activity), A1 (minimal activity), A2 (moderate activity), A3 (severe activity), A4 (lobular chronic hepatitis).

    Improved: Participants whose METAVIR activity score at up to Month-36 decreases by 1 or more units compared to baseline.

    No Change: Participants whose METAVIR activity score at up to Month-36 is the same as the baseline score.

    Worsened: Participants whose METAVIR activity score at up to Month-36 increases by 1 or more units compared to baseline.



Enrollment: 540
Study Start Date: October 2002
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PEG-Intron (peginterferon alfa-2b) 0.5 µg/kg Weekly (QW)
PEG-Intron 0.5 µg/kg Weekly (QW) subcutaneously (SC) as maintenance therapy for 36 months with 4-week follow-up
Biological: peginterferon alfa-2b (SCH 54031)
0.5 µg/kg Weekly QW SC for 36 months
No Intervention: Untreated Control

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age at entry in study P02370 (NCT00039871) 18-65 years;
  • Nonresponder to PEG-Intron plus Rebetol in study P02370

Exclusion Criteria:

  • Participants who did not participate in the P02370 study.
  • Any medical condition, including but not limited to decompensated liver disease, malignancy or substance abuse, that developed during the P02370 study which could interfere with the participant's participation in and completion of this study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided by Merck Sharp & Dohme Corp.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00049842     History of Changes
Other Study ID Numbers: P02570
Study First Received: November 14, 2002
Results First Received: October 7, 2010
Last Updated: April 25, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Fibrosis
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Liver Cirrhosis
Hepatitis C, Chronic
Pathologic Processes
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Peginterferon alfa-2b
Interferon-alpha
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 26, 2014