Safety and Efficacy of SCH 503034 in Previously Untreated Subjects With Chronic Hepatitis C Infected With Genotype 1 (Study P03523)
A Safety and Efficacy Study of SCH 503034 in Previously Untreated Subjects With Chronic Hepatitis C Infected With Genotype 1
2 other identifiers
interventional
765
0 countries
N/A
Brief Summary
This was an open-label, randomized safety and efficacy trial in adult, treatment-naïve Chronic Hepatitis C (CHC) participants with genotype 1 infection. The study conducted in 2 parts, compared standard-of-care PegIntron (1.5 μg/kg, once weekly \[QW\]), plus ribavirin (800 to 1400 mg/day), for 48 weeks to five treatment paradigms containing boceprevir (SCH 503034) 800 mg thrice a day (TID). The five treatments included boceprevir (BOC) plus standard-of-care for 28 or 48 weeks, with and without a 4-week lead-in with PegIntron (PEG) and ribavirin (RBV), and exploration of PegIntron plus low-dose ribavirin (400 to 1000 mg/day) plus boceprevir for 48 weeks.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jan 2007
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2007
CompletedFirst Submitted
Initial submission to the registry
January 17, 2007
CompletedFirst Posted
Study publicly available on registry
January 18, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2008
CompletedResults Posted
Study results publicly available
June 15, 2011
CompletedApril 5, 2017
March 1, 2017
1.6 years
January 17, 2007
May 13, 2011
March 8, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Participants With Sustained Virologic Response (SVR)
Participants with undetectable HCV-RNA at FW 24 up to EOF had achieved SVR. Participants missing data at FW 24 were considered to achieve SVR if 1. he/she had undetectable HCV-RNA at FW 12 or later 2. he/she returned later to the study center and had undetectable HCV-RNA. HCV-RNA in plasma samples was detected with reverse-transcriptase-polymerase chain reaction (RT-PCR) assay, with a lower limit of detection (LLD) of 29 international units/mL (IU/mL). A participant in Arm 2 with undetectable HCV-RNA at FW 24 had detectable HCV-RNA after FW 24. He is not considered to achieve SVR.
From follow-up week (FW) 24 up to end of follow-up (EOF)
Secondary Outcomes (7)
Number of Participants With SVR Based on a 4-week lead-in Treatment With PegIntron and Ribavirin
From FW 24 up to EOF
Number of Participants With SVR Based on Duration of Boceprevir Treatment
From FW 24 up to EOF
Number of Participants Negative for HCV-RNA at FW 12
At FW 12
Number of Participants Negative for HCV-RNA at 72 Weeks Post Randomization
72 weeks post randomization
Number of Participants With an Early Virologic Response (EVR) That Achieved SVR
At TW 12, and at FW 24 up to EOF
- +2 more secondary outcomes
Study Arms (8)
Arm 1. PEG +RBV for 48 Wks (Part I)
ACTIVE COMPARATORParticipants treated with PegIntron (1.5 μg/kg, once weekly \[QW\]) and Ribavirin (800 to 1400 mg/day) for 48 weeks. Participants with detectable HCV-RNA levels after 24 weeks of treatment had the option of crossing over to receive 24 weeks of PegIntron (1.5 μg/kg, QW), Ribavirin (800 to 1400 mg/day), and boceprevir (800 mg three times daily \[TID\]) for 24 additional weeks. The participants that crossed over to receive boceprevir formed Arm 8. The total treatment duration was up to 54 weeks.
Arm 2. PEG + RBV + BOC for 28 Wks (Part I)
EXPERIMENTALParticipants receiving boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 28 weeks.
Arm 3. PEG + RBV + BOC (from Wk 4) for 24 Wks (Part I)
EXPERIMENTALParticipants receiving a lead-in treatment with PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for 4 weeks, followed by boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 24 weeks.
Arm 4. PEG +RBV + BOC for 48 Wks (Part I)
EXPERIMENTALParticipants receiving boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 48 weeks.
Arm 5. PEG + RBV + BOC (from Wk 4) for 44 Wks (Part I)
EXPERIMENTALParticipants receiving a lead-in treatment with PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for 4 weeks, followed by boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 44 weeks.
Arm 6. PEG + RBV + BOC for 48 Wks (Part II)
EXPERIMENTALParticipants receiving PegIntron (1.5 μg/kg QW), ribavirin (800 to 1400 mg/day) and boceprevir (800 mg TID) for up to 48 weeks during Part II of the study. Part II was initiated after participants were fully enrolled for Part I.
Arm 7. PEG +Low-dose RBV + BOC for 48 Wks (Part II)
EXPERIMENTALParticipants receiving PegIntron (1.5 μg/kg QW), low-dose ribavirin (400 to 1000 mg/day) and boceprevir (800 mg TID) for up to 48 weeks (Arm 7) during Part II of the study. Part II was initiated after participants were fully enrolled for Part I.
Arm 8. PEG + RBV + BOC (from Wk 24) for 48 Wks (Part I)
EXPERIMENTALParticipants that started in Arm 1 and had detectable HCV-RNA levels after 24 weeks of treatment had the option of receiving boceprevir (800 mg TID) with PegIntron (1.5 μg/kg QW), and ribavirin (800 to 1400 mg/day). Participants that took the option of crossing over to receive PegIntron, ribavirin, and boceprevir (800 mg TID) for 24 additional weeks constitute Arm 8. The total treatment duration was up to 54 weeks.
Interventions
200 mg capsules taken as 800 mg orally three times daily (TID)
1.5 μg/kg subcutaneously (SC) once weekly (QW)
200 mg capsules in doses of 800 to 1400 mg/day (based on weight) taken orally divided twice daily
200 mg capsules in doses of 400 to 1000 mg/day (based on weight) taken orally divided twice daily
Eligibility Criteria
You may qualify if:
- Age between 18 and 60 years;
- Body weight between 45 and 125 kg;
- Documented chronic hepatitis C genotype 1;
- Liver biopsy with histology consistent with chronic hepatitis and no other etiology for chronic liver disease within of 5 years of Day 1;
- Participant and participant's partner(s) must each agree to use acceptable methods of contraception 2 weeks prior to Day 1 and at least 6 months after the last dose of study medication;
- Written informed consent.
You may not qualify if:
- Include, but are not limited to, the following:
- Prior treatment for hepatitis C;
- Co-infection with HIV or hepatitis B virus (HBsAg positive);
- Evidence of decompensated liver disease;
- Diabetic and hypertensive participants with clinically significant ocular exam findings;
- Pre-existing psychiatric condition, including but not limited to:
- Current moderate or severe depression;
- History of depression associated with any of the following:
- Hospitalization for depression;
- Electroconvulsive therapy for depression;
- Depression that resulted in a prolonged absence from work and/or significant disruption of daily functions;
- Suicidal or homicidal ideation and/or attempt;
- History of severe psychiatric disorders (including but not limited to schizophrenia, psychosis, bipolar disorder, post-traumatic stress disorder or mania);
- Past history or current use of lithium;
- Past history or current use of antipsychotic drugs for listed conditions.
- +9 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Kwo PY, Lawitz EJ, McCone J, Schiff ER, Vierling JM, Pound D, Davis MN, Galati JS, Gordon SC, Ravendhran N, Rossaro L, Anderson FH, Jacobson IM, Rubin R, Koury K, Pedicone LD, Brass CA, Chaudhri E, Albrecht JK; SPRINT-1 investigators. Efficacy of boceprevir, an NS3 protease inhibitor, in combination with peginterferon alfa-2b and ribavirin in treatment-naive patients with genotype 1 hepatitis C infection (SPRINT-1): an open-label, randomised, multicentre phase 2 trial. Lancet. 2010 Aug 28;376(9742):705-16. doi: 10.1016/S0140-6736(10)60934-8. Epub 2010 Aug 6.
PMID: 20692693DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Senior Vice President,Global Clinical Development
- Organization
- Merck, Sharp and Dohme
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 17, 2007
First Posted
January 18, 2007
Study Start
January 1, 2007
Primary Completion
August 1, 2008
Study Completion
November 1, 2008
Last Updated
April 5, 2017
Results First Posted
June 15, 2011
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