Chronic Hepatitis CPhase 2NCT00160251

Boceprevir (SCH 503034) Plus Peg-Intron, With and Without Added Ribavirin, in Patients With Chronic Hepatitis C, Genotype 1, Who Did Not Respond to Previous Treatment With Peginterferon Alfa Plus Ribavirin (Study P03659AM2)(COMPLETED)

A Phase 2 study testing Boceprevir (BOC), PegIntron (PEG) and Ribavirin (RBV) in people with Chronic Hepatitis C, run by Merck Sharp & Dohme LLC.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The primary objective of this study is to determine the safe and effective dose range of boceprevir (SCH 503034) in combination with PEG-Intron in adult subjects who have chronic hepatitis C without cirrhosis, and who have failed an adequate course of combination therapy with peginterferon-alfa plus ribavirin. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Chronic Hepatitis C
What is being tested?: Boceprevir (BOC), PegIntron (PEG) and Ribavirin (RBV)
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 357 participants
Where: No sites listed yet
Study dates: Sep 2005to Jul 2007
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Documented infection with chronic hepatitis C (CHC), genotype 1.
Documented failure to respond to an adequate course of treatment (minimum 12 weeks) with peginterferon-alfa plus ribavirin (failure defined as <2 log drop in HCV-RNA after 12 weeks of therapy or those who never become Hepatitis C Virus Ribonucleic Acid (HCV)-RNA negative)
No evidence of cirrhosis on liver biopsy.
Results of physical examination and laboratory tests within specified ranges.
Abstinence from use of abused substances.

Who cannot join

Women who are pregnant or nursing a child.
Patients with cirrhosis, co-infection with Hepatitis B or human immunodeficiency virus (HIV), and African-American patients (by protocol amendment 2, African-American patients can enroll).
Previous treatment with any Hepatitis C Virus (HCV) polymerase or protease inhibitor.
Patients who relapsed following response to previous treatment.
Evidence of advanced liver disease, or liver disease from a cause other than CHC.
Pre-existing psychiatric condition.

About this study

Official title: PEG-Intron/REBETOL vs PEG-Intron/ SCH 503034 With and Without Ribavirin in Chronic Hepatitis C Virus Genotype 1 (HCV-1) Peginterferon Alfa/Ribavirin Nonresponders: A SCH 503034 Dose-Finding Phase 2 Study

Conditions: Chronic Hepatitis C
Being tested: Boceprevir (BOC), PegIntron (PEG), Ribavirin (RBV)
Keywords: PEG-Intron, Ribavirin, Protease Inhibitor
Medical subject headings: Hepatitis C, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Boceprevir (BOC)Drug
Also called SCH 503034
100 or 200 mg capusles taken orally as 100 mg, 200 mg, 400 mg, or 800 mg TID
PegIntron (PEG)Biological
1.5 mcg/kg weekly subcutaneously
Ribavirin (RBV)Drug
200 mg capsules taken twice daily (BID) (total daily dose of 800-1400 mg/day, depending on weight [weight-based dosing {WBD}])

Study groups in NCT00160251
Study group	Role	What they receive
Arm 1A: PegIntron (PEG) + Ribavirin (RBV)	Active comparator	A single dose of PEG is given first, followed 1 week later by PEG + RBV for 12 weeks. If HCV-RNA is undetected, PEG + RBV will continue for another 36 weeks. Receives: Biological: PegIntron (PEG); Drug: Ribavirin (RBV)
Arm 1B: PegIntron (PEG)+Ribavirin (RBV)+Boceprevir (BOC) 400	Active comparator	A single dose of PEG is given first, followed 1 week later by PEG + RBV for 12 weeks. If HCV-RNA is detectable, BOC 400 mg TID will be added for 36 weeks. By second protocol amendment to P03659, participants will be rolled over into Arm 8 for the remainder of the treatment period. Receives: Drug: Boceprevir (BOC); Biological: PegIntron (PEG); Drug: Ribavirin (RBV)
Arm 2: PegIntron (PEG) + Boceprevir (BOC) 100 (48 weeks)	Experimental	A single dose of PEG is given first, followed 1 week later by PEB + BOC 100 for 48 weeks. By second protocol amendment to P03659, participants will be rolled over into Arm 8 for the remainder of the treatment period. Receives: Drug: Boceprevir (BOC); Biological: PegIntron (PEG)
Arm 3: PegIntron (PEG) + Boceprevir (BOC) 200 (48 Weeks)	Experimental	A single dose of PEG is given first, followed 1 week later by PEG + BOC 200 for 48 weeks. By second protocol amendment to P03659, participants will be rolled over into Arm 8 for the remainder of the treatment period. Receives: Drug: Boceprevir (BOC); Biological: PegIntron (PEG)
Arm 4: PegIntron (PEG) + Boceprevir (BOC) 400 (48 weeks)	Experimental	A single dose of PEG is given first, followed 1 week later by PEG + BOC 400 for 48 weeks. By second protocol amendment to P03659, participants will be rolled over into Arm 8 for the remainder of the treatment period. Receives: Drug: Boceprevir (BOC); Biological: PegIntron (PEG)
Arm 5: PegIntron (PEG)+Ribavirin (RBV)+Boceprevir (BOC) 400	Experimental	A single dose of PEG is given first, followed 1 week later by PEG + RBV + BOC 400 for 48 weeks. By second protocol amendment to P03659, participants will be rolled over into Arm 8 for the remainder of the treatment period. Receives: Drug: Boceprevir (BOC); Biological: PegIntron (PEG); Drug: Ribavirin (RBV)
Arm 6: PegIntron (PEG) + Boceprevir (BOC) 400 (24 Weeks)	Experimental	A single dose of PEG is given first, followed 1 week later by PEG + BOC 400 for 24 weeks. By second protocol amendment to P03659, participants will be rolled over into Arm 8 for the remainder of the treatment period. Receives: Drug: Boceprevir (BOC); Biological: PegIntron (PEG)
Arm 7: PegIntron (PEG) + Boceprevir (BOC) 800	Experimental	By first protocol amendment to P03659, this non-randomized arm is added. A single dose of PEG is given first, followed 1 week later by PEG + BOC 800 for 24 weeks. By second protocol amendment to P03659, participants will be rolled over into Arm 8 for the remainder of the treatment period. Receives: Drug: Boceprevir (BOC); Biological: PegIntron (PEG)
Arm 8: PegIntron (PEG)+Ribavirin (RBV)+Boceprevir (BOC) 800	Experimental	By second protocol amendment to P03659, participants from all arms except Arm 1A will be rolled over into PEG + RBV + BOC 800 for the remainder of the treatment period. Receives: Drug: Boceprevir (BOC); Biological: PegIntron (PEG); Drug: Ribavirin (RBV)

What is being measured

The primary outcome is the main question the study is designed to answer.

Percent of Participants Who Were Hepatitis C Virus Ribonucleic Acid (HCV-RNA) Negative at the End of Treatment (EoT)
Sustained Viral Response (SVR) was defined as the percentage of participants with HCV-RNA undetectable at the follow-up Week 24.
All percentages were based on the total number of participants originally randomized/enrolled to that particular arm.
For Arm 1B, the denominator for the percentages was the number who received at least 1 dose of BOC.
Arm 1A was not analyzed.
Measured: Baseline up to Week 49
Percent of Participants Who Achieved Sustained Virologic Response (SVR)
SVR was defined as the percentage of participants with Hepatitis C Virus Ribonucleic Acid (HCV-RNA) undetectable at the follow-up Week 24.
All percentages were based on the total number of participants originally randomized/enrolled to that particular arm.
For Arm 1B, the denominator for the percentages was the number who received at least 1 dose of BOC.
Arm 1A was not analyzed.
Measured: Baseline up to Week 73 [24 weeks after end of treatment (EoT)]

Secondary outcomes (10)

Percent of Participants Who Achieved Sustained Viral Response (SVR) by Time to First Negative HCV-RNA
Percentage of participants who became HCV-RNA undetectable within the first 13 weeks and subsequently became HCV-RNA positive were not considered negative for this analysis.
Measured: Baseline up to Week 73 [24 weeks after EoT]
Percentage of Participants Who Were HCV-RNA Negative at EoT After Receiving 1 Week of Treatment With PegIntron (PEG) by Log Drop
For each log drop category (<0, 0 to 0.5, 0.5 to <1, 1 to <1.5, ≥1.5, and Missing), the percentage of participants receiving combination therapy who were HCV-RNA negative at EoT (Week 49) was calculated as follows:
Number of participants in a log category who were HCV-RNA negative divided by the total number of participants in that log drop category (n).
Percentages were NOT derived using treatment arm N values. The sum of the n values for all 6 log drop categories within a treatment arm equals the overall N for that treatment group.
Measured: Week 1 and Week 49
Percent of Participants With Virologic Response Prior to Amendment 2
Virologic response was defined as the percentage of participants with Hepatitis C Virus Ribonucleic Acid (HCV-RNA) ≤10,000 IU/mL.
Measured: Week 3, Week 5, Week 13
Peak Plasma Concentration of Boceprevir (BOC)
All plasma samples were assayed using a validated liquid chromatography with tandem mass spectrometric detection (LCMS/MS) method.
Measured: All visits during treatment (baseline to Week 49) except Day 1 of Week 1
Area Under the Plasma Concentration-time Curve of Boceprevir Plasma Concentration for an 8-hour Dosing Period
All plasma samples were assayed using a validated liquid chromatography with tandem mass spectrometric detection (LCMS/MS) method.
The dosing interval of 8 hours is represented as the hr in the unit of measure.
Measured: All visits during treatment (baseline to Week 49) except Day 1 of Week 1
Trough Plasma Concentration Level
All plasma samples were assayed using a validated liquid chromatography with tandem mass spectrometric detection (LCMS/MS) method.
Measured: All visits during treatment (baseline to Week 49) except Day 1 of Week 1
Change in Alanine Aminotransferase (ALT) Levels
Change in ALT levels during initial treatment regimen and after rolling into amendment 2 as compared to baseline.
Measured: Baseline up to dosing change (> 25 weeks)
Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on Arms 2 (PEG+BOC 100), 3 (PEG+BOC 200), 4 (PEG+BOC 400 [48 Weeks]), 6 (PEG+BOC 400 [24 Weeks])
Log drop at baseline of dosing change = difference of log viral loads between baseline (closest to the treatment begin date) and dosing change baseline (virology value closest to the dosing change begin date).
Measured: From dosing change to end of follow-up (Week 73)(up to 48 weeks)
Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Rebetol (RVB) + Boceprevir (BOC) 400 (Arm 5)
Log drop at baseline of dosing change = difference of log viral loads between baseline (closest to the treatment begin date) and dosing change baseline (virology value closest to the dosing change begin date).
Measured: From dosing change to end of follow-up (Week 73)(up to 48 weeks)
Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Boceprevir (BOC) 800 (Arm 7)
Log drop at baseline of dosing change = difference of log viral loads between baseline (closest to the treatment begin date) and dosing change baseline (virology value closest to the dosing change begin date).
Measured: From dosing change to end of follow-up (Week 73) (up to 48 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2005Jul 2007

First posted12 Sep 2005 (estimated)
Study startSep 2005
Primary completionJul 2007
Study completionJul 2007

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Chronic Hepatitis CStudies of the same condition, open and under way.
More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Enrolment: 357 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00160251
Sponsor's protocol ID: P03659
Status last verified: Oct 2015
First submitted: 8 Sep 2005
Last updated: 14 Oct 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 4
People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents
Diabetes Mellitus, Hepatitis C, Chronic
RecruitingObservational study
"Constitution of a Biological Collection to Establish Preclinical Translational Models for the Study of Tumors and Chronic Liver Diseases".
Chronic Liver Disease and Cirrhosis, Liver Cancer
Active, not recruitingPhase 4
Sofosbuvir/Velpatasvir Treatment of Chronic Hepatitis C During Pregnancy
Hepatitis C, Chronic, Pregnancy; Infection
Enrolling by invitationObservational study
Comparative Autoantibody and Immunologic Cell Marker Study
Autoimmune Diseases, Lupus Erythematosus, Systemic

All Chronic Hepatitis C trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: PEG-Intron/REBETOL vs PEG-Intron/ SCH 503034 With and Without Ribavirin in Chronic Hepatitis C Virus Genotype 1 (HCV-1) Peginterferon Alfa/Ribavirin Nonresponders: A SCH 503034 Dose-Finding Phase 2 Study
ClinicalTrials.gov ID: NCT00160251
Acronym / sponsor ID: P03659
Conditions: Chronic Hepatitis C
Keywords: PEG-Intron, Ribavirin, Protease Inhibitor
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 357 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: Sep 2005
Primary completion: Jul 2007 (actual)
Study completion: Jul 2007 (actual)
First posted: 12 Sep 2005 (estimated)
Results: Posted 29 Dec 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Number of arms: 9

Arm	Type	Receives
Arm 1A: PegIntron (PEG) + Ribavirin (RBV)	Active comparator	Biological: PegIntron (PEG), Drug: Ribavirin (RBV)A single dose of PEG is given first, followed 1 week later by PEG + RBV for 12 weeks. If HCV-RNA is undetected, PEG + RBV will continue for another 36 weeks.
Arm 1B: PegIntron (PEG)+Ribavirin (RBV)+Boceprevir (BOC) 400	Active comparator	Drug: Boceprevir (BOC), Biological: PegIntron (PEG), Drug: Ribavirin (RBV)A single dose of PEG is given first, followed 1 week later by PEG + RBV for 12 weeks. If HCV-RNA is detectable, BOC 400 mg TID will be added for 36 weeks. By second protocol amendment to P03659, participants will be rolled over into Arm 8 for the remainder of the treatment period.
Arm 2: PegIntron (PEG) + Boceprevir (BOC) 100 (48 weeks)	Experimental	Drug: Boceprevir (BOC), Biological: PegIntron (PEG)A single dose of PEG is given first, followed 1 week later by PEB + BOC 100 for 48 weeks. By second protocol amendment to P03659, participants will be rolled over into Arm 8 for the remainder of the treatment period.
Arm 3: PegIntron (PEG) + Boceprevir (BOC) 200 (48 Weeks)	Experimental	Drug: Boceprevir (BOC), Biological: PegIntron (PEG)A single dose of PEG is given first, followed 1 week later by PEG + BOC 200 for 48 weeks. By second protocol amendment to P03659, participants will be rolled over into Arm 8 for the remainder of the treatment period.
Arm 4: PegIntron (PEG) + Boceprevir (BOC) 400 (48 weeks)	Experimental	Drug: Boceprevir (BOC), Biological: PegIntron (PEG)A single dose of PEG is given first, followed 1 week later by PEG + BOC 400 for 48 weeks. By second protocol amendment to P03659, participants will be rolled over into Arm 8 for the remainder of the treatment period.
Arm 5: PegIntron (PEG)+Ribavirin (RBV)+Boceprevir (BOC) 400	Experimental	Drug: Boceprevir (BOC), Biological: PegIntron (PEG), Drug: Ribavirin (RBV)A single dose of PEG is given first, followed 1 week later by PEG + RBV + BOC 400 for 48 weeks. By second protocol amendment to P03659, participants will be rolled over into Arm 8 for the remainder of the treatment period.
Arm 6: PegIntron (PEG) + Boceprevir (BOC) 400 (24 Weeks)	Experimental	Drug: Boceprevir (BOC), Biological: PegIntron (PEG)A single dose of PEG is given first, followed 1 week later by PEG + BOC 400 for 24 weeks. By second protocol amendment to P03659, participants will be rolled over into Arm 8 for the remainder of the treatment period.
Arm 7: PegIntron (PEG) + Boceprevir (BOC) 800	Experimental	Drug: Boceprevir (BOC), Biological: PegIntron (PEG)By first protocol amendment to P03659, this non-randomized arm is added. A single dose of PEG is given first, followed 1 week later by PEG + BOC 800 for 24 weeks. By second protocol amendment to P03659, participants will be rolled over into Arm 8 for the remainder of the treatment period.
Arm 8: PegIntron (PEG)+Ribavirin (RBV)+Boceprevir (BOC) 800	Experimental	Drug: Boceprevir (BOC), Biological: PegIntron (PEG), Drug: Ribavirin (RBV)By second protocol amendment to P03659, participants from all arms except Arm 1A will be rolled over into PEG + RBV + BOC 800 for the remainder of the treatment period.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Documented infection with chronic hepatitis C (CHC), genotype 1.
Documented failure to respond to an adequate course of treatment (minimum 12 weeks) with peginterferon-alfa plus ribavirin (failure defined as <2 log drop in HCV-RNA after 12 weeks of therapy or those who never become Hepatitis C Virus Ribonucleic Acid (HCV)-RNA negative)
No evidence of cirrhosis on liver biopsy.
Results of physical examination and laboratory tests within specified ranges.
Abstinence from use of abused substances.

Key exclusion criteria (6 listed)

Women who are pregnant or nursing a child.
Patients with cirrhosis, co-infection with Hepatitis B or human immunodeficiency virus (HIV), and African-American patients (by protocol amendment 2, African-American patients can enroll).
Previous treatment with any Hepatitis C Virus (HCV) polymerase or protease inhibitor.
Patients who relapsed following response to previous treatment.
Evidence of advanced liver disease, or liver disease from a cause other than CHC.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Boceprevir (BOC)Also: SCH 503034100 or 200 mg capusles taken orally as 100 mg, 200 mg, 400 mg, or 800 mg TID	Drug	Arm 1B: PegIntron (PEG)+Ribavirin (RBV)+Boceprevir (BOC) 400, Arm 2: PegIntron (PEG) + Boceprevir (BOC) 100 (48 weeks), Arm 3: PegIntron (PEG) + Boceprevir (BOC) 200 (48 Weeks), Arm 4: PegIntron (PEG) + Boceprevir (BOC) 400 (48 weeks), Arm 5: PegIntron (PEG)+Ribavirin (RBV)+Boceprevir (BOC) 400, Arm 6: PegIntron (PEG) + Boceprevir (BOC) 400 (24 Weeks), Arm 7: PegIntron (PEG) + Boceprevir (BOC) 800, Arm 8: PegIntron (PEG)+Ribavirin (RBV)+Boceprevir (BOC) 800
PegIntron (PEG)1.5 mcg/kg weekly subcutaneously	Biological	Arm 1A: PegIntron (PEG) + Ribavirin (RBV), Arm 1B: PegIntron (PEG)+Ribavirin (RBV)+Boceprevir (BOC) 400, Arm 2: PegIntron (PEG) + Boceprevir (BOC) 100 (48 weeks), Arm 3: PegIntron (PEG) + Boceprevir (BOC) 200 (48 Weeks), Arm 4: PegIntron (PEG) + Boceprevir (BOC) 400 (48 weeks), Arm 5: PegIntron (PEG)+Ribavirin (RBV)+Boceprevir (BOC) 400, Arm 6: PegIntron (PEG) + Boceprevir (BOC) 400 (24 Weeks), Arm 7: PegIntron (PEG) + Boceprevir (BOC) 800, Arm 8: PegIntron (PEG)+Ribavirin (RBV)+Boceprevir (BOC) 800
Ribavirin (RBV)200 mg capsules taken twice daily (BID) (total daily dose of 800-1400 mg/day, depending on weight [weight-based dosing {WBD}])	Drug	Arm 1A: PegIntron (PEG) + Ribavirin (RBV), Arm 1B: PegIntron (PEG)+Ribavirin (RBV)+Boceprevir (BOC) 400, Arm 5: PegIntron (PEG)+Ribavirin (RBV)+Boceprevir (BOC) 400, Arm 8: PegIntron (PEG)+Ribavirin (RBV)+Boceprevir (BOC) 800

Primary outcome

Percent of Participants Who Were Hepatitis C Virus Ribonucleic Acid (HCV-RNA) Negative at the End of Treatment (EoT)
Time frame: Baseline up to Week 49
Sustained Viral Response (SVR) was defined as the percentage of participants with HCV-RNA undetectable at the follow-up Week 24. All percentages were based on the total number of participants originally randomized/enrolled to that particular arm. For Arm 1B, the denominator for the percentages was the number who received at least 1 dose of BOC. Arm 1A was not analyzed.
Percent of Participants Who Achieved Sustained Virologic Response (SVR)
Time frame: Baseline up to Week 73 [24 weeks after end of treatment (EoT)]
SVR was defined as the percentage of participants with Hepatitis C Virus Ribonucleic Acid (HCV-RNA) undetectable at the follow-up Week 24. All percentages were based on the total number of participants originally randomized/enrolled to that particular arm. For Arm 1B, the denominator for the percentages was the number who received at least 1 dose of BOC. Arm 1A was not analyzed.

10 secondary outcomes

Percent of Participants Who Achieved Sustained Viral Response (SVR) by Time to First Negative HCV-RNA
Time frame: Baseline up to Week 73 [24 weeks after EoT]
Percentage of Participants Who Were HCV-RNA Negative at EoT After Receiving 1 Week of Treatment With PegIntron (PEG) by Log Drop
Time frame: Week 1 and Week 49
Percent of Participants With Virologic Response Prior to Amendment 2
Time frame: Week 3, Week 5, Week 13
Peak Plasma Concentration of Boceprevir (BOC)
Time frame: All visits during treatment (baseline to Week 49) except Day 1 of Week 1
Area Under the Plasma Concentration-time Curve of Boceprevir Plasma Concentration for an 8-hour Dosing Period
Time frame: All visits during treatment (baseline to Week 49) except Day 1 of Week 1
Trough Plasma Concentration Level
Time frame: All visits during treatment (baseline to Week 49) except Day 1 of Week 1
Change in Alanine Aminotransferase (ALT) Levels
Time frame: Baseline up to dosing change (> 25 weeks)
Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on Arms 2 (PEG+BOC 100), 3 (PEG+BOC 200), 4 (PEG+BOC 400 [48 Weeks]), 6 (PEG+BOC 400 [24 Weeks])
Time frame: From dosing change to end of follow-up (Week 73)(up to 48 weeks)
Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Rebetol (RVB) + Boceprevir (BOC) 400 (Arm 5)
Time frame: From dosing change to end of follow-up (Week 73)(up to 48 weeks)
Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Boceprevir (BOC) 800 (Arm 7)
Time frame: From dosing change to end of follow-up (Week 73) (up to 48 weeks)

Results and safety

Results posted to the registry on 29 Dec 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Arm 1A: PEG + RBV	15	6
Arm 1B: PEG + RBV + BOC	34	28
Arm 2: PEG + BOC 100 (48 Weeks)	48	4
Arm 3: PEG + BOC 200 (48 Weeks)	49	9
Arm 5: PEG + RBV + BOC 400	49	21
ARM 4+6: PEG + BOC 400 (24 + 48 Weeks)	97	14
Arm 7: PEG + BOC 800	65	61
Arm 8: PEG + RBV + BOC 800	0	0

Primary outcome: Percent of Participants Who Were Hepatitis C Virus Ribonucleic Acid (HCV-RNA) Negative at the End of Treatment (EoT)

Time frame: Baseline up to Week 49. Number. Unit: Percent of participants

Measure	Arm 1B: PEG + RBV + BOC 400 n = 40	Arm 2: PEG + BOC 100 (48 Weeks) n = 48	Arm 3: PEG + BOC 200 (48 Weeks) n = 49	Arms 4 + 6: PEG + BOC 400 (24 + 48 Weeks) n = 97	Arm 5: PEG + RBV + BOC 400 n = 49	Arm 7: PEG + BOC 800 n = 65
Value	35.0	6.3	16.3	13.4	20.4	21.5

Population analysed: For PEG + RBV + BOC number of participants was number who received at least one dose of BOC. For all others, it was number of randomized participants. The PEG + BOC 800 arm was not randomized.

Primary outcome: Percent of Participants Who Achieved Sustained Virologic Response (SVR)

Time frame: Baseline up to Week 73 [24 weeks after end of treatment (EoT)]. Number. Unit: Percent of participants

Measure	Arm 1B: PEG + RBV + BOC 400 n = 40	Arm 2: PEG + BOC 100 (48 Weeks) n = 48	Arm 3: PEG + BOC 200 (48 Weeks) n = 49	Arms 4 + 6: PEG + BOC 400 (24 + 48 Weeks) n = 97	Arm 5: PEG + RBV + BOC 400 n = 49	Arm 7: PEG + BOC 800 n = 65
Value	7.5	2.1	12.2	5.2	14.3	4.6

10 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
PEG + RBV	2 of 15 (13.3%)	14 of 15 (93.3%)	Not reported
PEG + RBV + BOC 400 (24 Weeks)	1 of 34 (2.9%)	33 of 34 (97.1%)	Not reported
PEG + BOC 100 (48 Weeks)	2 of 48 (4.2%)	48 of 48 (100%)	Not reported
PEG + BOC 200 (48 Weeks)	4 of 49 (8.2%)	48 of 49 (98%)	Not reported
PEG + RBV + BOC 400 (48 Weeks)	2 of 49 (4.1%)	47 of 49 (95.9%)	Not reported
PEG + BOC 400 (24 + 48 Weeks)	4 of 97 (4.1%)	96 of 97 (99%)	Not reported
PEG + BOC 800 (24 Weeks)	3 of 65 (4.6%)	64 of 65 (98.5%)	Not reported
PEG + RBV + BOC 800	12 of 143 (8.4%)	136 of 143 (95.1%)	Not reported

Limitations and caveats (from the sponsor): The implementation of amendment 2 led to changes in boceprevir dose in all treatment arms and different overall lengths of therapy within the same treatment arm, making the SVR endpoint uninterpretable.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Boceprevir (BOC), PegIntron (PEG) and Ribavirin (RBV) in people with Chronic Hepatitis C, run by Merck Sharp & Dohme LLC.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Dec 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent of Participants Who Were Hepatitis C Virus Ribonucleic Acid (HCV-RNA) Negative at the End of Treatment (EoT) (time frame: Baseline up to Week 49). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00160251.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2015.