Peginterferon Dose Evaluations for Previously Untreated Subjects With Chronic Hepatitis C Infected With Genotype 1 (Study P03471)
Comparison of PEG-Intron 1.5µg/kg/wk Plus REBETOL vs PEG-Intron 1µg/kg/wk Plus REBETOL vs PEGASYS 180µg/wk Plus COPEGUS in Previously Untreated Adult Subjects With Chronic Hepatitis C Infected With Genotype 1
2 other identifiers
interventional
4,469
0 countries
N/A
Brief Summary
The objective is to compare the safety and efficacy of the following three treatment regimens in previously untreated adult subjects with chronic hepatitis C infected with Genotype 1: (1) PegIntron 1.5 µg/kg/wk in combination with weight based REBETOL (800-1400 mg/day); (2) PegIntron 1µg/kg/wk in combination with weight based REBETOL (800-1400 mg/day); and (3) PEGASYS 180 µg/wk plus COPEGUS 1000-1200 mg/day.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Mar 2004
Typical duration for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2004
CompletedFirst Submitted
Initial submission to the registry
April 20, 2004
CompletedFirst Posted
Study publicly available on registry
April 22, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2007
CompletedResults Posted
Study results publicly available
October 30, 2009
CompletedApril 4, 2017
March 1, 2017
3.7 years
April 20, 2004
November 3, 2008
March 7, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Sustained Virologic Response (SVR) Rate
SVR rate is the percentage of participants with undetectable hepatitis C virus ribonucleic acid (HCV-RNA) at the end of the 24-week post-treatment follow-up.
Assessed at the end of a 24-week post-treatment follow-up
Secondary Outcomes (3)
Mean Change From Baseline in the Log Viral Load at Treatment Week 4
Assessed at Baseline and Treatment Week 4
Virologic Response Rate at Treatment Week 12
Assessed at Treatment Week 12
Mean Change From Baseline in the Log Viral Load at Treatment Week 2
Assessed at Baseline and Treatment Week 2
Study Arms (3)
PegIntron 1.5 ug/kg/wk plus REBETOL
EXPERIMENTALPegIntron (peginterferon alfa-2b; SCH 54031) 1.5 ug/kg/week in combination with weight-based REBETOL (ribavirin; SCH 18908) 800-1400 mg/day administered for 48 weeks with 24-week post-treatment follow-up
PegIntron 1.0 ug/kg/wk plus REBETOL
EXPERIMENTALPegIntron (peginterferon alfa-2b; SCH 54031) 1.0 ug/kg/week in combination with weight-based REBETOL (ribavirin; SCH 18908) 800-1400 mg/day administered for 48 weeks with 24-week post-treatment follow-up
PEGASYS 180 ug/wk Plus COPEGUS
ACTIVE COMPARATORPEGASYS (peginterferon alfa-2a) 180 ug/week plus COPEGUS (ribavirin) 1000-1200 mg/day administered for 48 weeks with 24-week post-treatment follow-up
Interventions
1.5 ug/kg/week subcutaneously (SC) for 48 weeks
weight based dose 800-1400 mg/day orally (PO) for 48 weeks
180 ug/week SC administered for 48 weeks
1000-1200 mg/day PO for 48 weeks
Eligibility Criteria
You may qualify if:
- Previously untreated adults with chronic hepatitis C (hepatitis C virus ribonucleic acid \[HCV RNA\] quantitative polymerase chain reaction \[qPCR\] plasma positive)
- Individuals with HCV genotype 1 (mixed 1a/1b is acceptable)
- Compensated liver disease
- Pretreatment liver biopsy slides available
- Adults aged 18-70
- Individuals weighing 88-275 pounds (40-125 kg)
- Free from substance abuse for past 2 years
- Those suffering from diabetes and/or hypertension must have normal eye exams and retinal photographs (these will be done as part of the study before hepatitis C treatment is given)
- Patients and partners of patients willing to use adequate contraception during the course of the study
- Hematology laboratory results of:
- Hemoglobin (HGB) ≥ 12 g/dL for females or ≥ 13g/dL for males
- White Blood Cell Count (WBC) ≥ 3,000/mm\^3
- Neutrophils ≥ 1,500/mm\^3
- Platelets ≥ 80,000/mm\^3
- Chemistry laboratory results of:
- +3 more criteria
You may not qualify if:
- Previous hepatitis C treatment
- Pregnant women or partners of pregnant women
- Patients or partners of patients who intend to become pregnant any time during the 48 weeks
- Women who are breastfeeding
- Individuals with liver disease not caused by hepatitis C
- Individuals infected with the hepatitis B virus and/or human immunodeficiency virus (HIV)
- Patients with a history of liver cancer (hepatocellular carcinoma)
- Known blood disorders such as hemoglobinopathy, coagulopathy, or glucose-6-phosphate dehydrogenase \[G6PD\] deficiency
- Body organ transplant
- Any known or suspected cancer within the past 5 years
- Individuals who currently use epoetin \[EPO\], granulocyte colony stimulating factor \[G-CSF\] and/or granulocyte monocyte colony stimulating factor \[GM-CSF\]
- Those having a history of or active clinical gout
- Individuals who have chronic pulmonary disease
- Individuals who have a medical condition that would likely require systemic steroids
- Those with a history of central nervous system (CNS trauma) or seizure disorders
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (2)
McHutchison JG, Lawitz EJ, Shiffman ML, Muir AJ, Galler GW, McCone J, Nyberg LM, Lee WM, Ghalib RH, Schiff ER, Galati JS, Bacon BR, Davis MN, Mukhopadhyay P, Koury K, Noviello S, Pedicone LD, Brass CA, Albrecht JK, Sulkowski MS; IDEAL Study Team. Peginterferon alfa-2b or alfa-2a with ribavirin for treatment of hepatitis C infection. N Engl J Med. 2009 Aug 6;361(6):580-93. doi: 10.1056/NEJMoa0808010. Epub 2009 Jul 22.
PMID: 19625712RESULTMelia MT, Muir AJ, McCone J, Shiffman ML, King JW, Herrine SK, Galler GW, Bloomer JR, Nunes FA, Brown KA, Mullen KD, Ravendhran N, Ghalib RH, Boparai N, Jiang R, Noviello S, Brass CA, Albrecht JK, McHutchison JG, Sulkowski MS; IDEAL Study Team. Racial differences in hepatitis C treatment eligibility. Hepatology. 2011 Jul;54(1):70-8. doi: 10.1002/hep.24358.
PMID: 21488082DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Senior Vice President, Global Clinical Development
- Organization
- Merck Sharp & Dohme Corp.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- 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
April 20, 2004
First Posted
April 22, 2004
Study Start
March 1, 2004
Primary Completion
November 1, 2007
Study Completion
November 1, 2007
Last Updated
April 4, 2017
Results First Posted
October 30, 2009
Record last verified: 2017-03
Data Sharing
- IPD Sharing
- Will share
http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final\_Updated%20July\_9\_2014.pdf http://engagezone.msd.com/ds\_documentation.php