Chronic Hepatitis C Genotype 1Phase 3NCT01425203
The Effect of Boceprevir in Russian Participants Diagnosed With Chronic Hepatitis C Genotype 1 (P08160)
A Phase 3 study testing Boceprevir, peginterferon alfa-2b and Ribavirin in people with Chronic Hepatitis C Genotype 1, run by Merck Sharp & Dohme LLC.
Trial summary
The purpose of this study is to determine whether Boceprevir (BOC, SCH 503034, MK-3034) in combination with Peginterferon Alfa 2-b (PEG) plus Ribavirin (RBV) [PEG+RBV=PR] is effective in the treatment of chronic hepatitis C (CHC) genotype 1 among the Russian population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Hepatitis C Genotype 1
- What is being tested?
- Boceprevir, peginterferon alfa-2b and Ribavirin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 238 participants
- Where
- No sites listed yet
- Study dates
- 23 Nov 2011to 21 Oct 2013
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- body weight ≥40 kg and ≤125 kg
- previously documented CHC genotype 1 infection;
- must have a liver biopsy with histology consistent with CHC and no other etiology
- if cirrhosis present, must have an ultrasound within 6 months of the screening visit (or between screening and Day 1) with no findings suspicious for hepatocellular carcinoma (HCC)
- agree to use acceptable methods of contraception with partner
- previously untreated with pegylated-interferon (either alfa-2a or alfa-2b) plus RBV or failing prior treatment with pegylated-interferon (either alfa-2a or alfa-2b) plus RBV
Who cannot join
- co-infected with the human immunodeficiency virus (HIV) or hepatitis B virus (Hepatitis B surface antigen [HBsAg] positive).
- required discontinuation of previous interferon or ribavirin regimen for an adverse event (possibly or probably related)
- treatment with ribavirin within 90 days and any interferon-alpha, based on the amendment, should be within 1 month prior to screening
- treatment with any investigational drug within 30 days of the screening visit in this trial
- evidence of decompensated liver disease including, but not limited to, a history or presence of clinical ascites, bleeding varices, or hepatic encephalopathy
- diabetic and/or hypertensive with clinically significant ocular examination findings
- clinical diagnosis of substance abuse of specified drugs within specified timeframes
- any known pre-existing medical condition that could interfere with the participant's participation in and completion of the trial
About this study
Official title: Safety and Efficacy of Boceprevir in Combination With Peginterferon Alfa-2b Plus Ribavirin for Treatment of Chronic Hepatitis C Genotype 1 in Russia: Previously Untreated Patients and Patients Who Failed Prior Treatment With Pegylated-Interferon Plus Ribavirin
The purpose of this study is to determine whether Boceprevir (BOC, SCH 503034, MK-3034) in combination with Peginterferon Alfa 2-b (PEG) plus Ribavirin (RBV) [PEG+RBV=PR] is effective in the treatment of chronic hepatitis C (CHC) genotype 1 among the Russian population. The primary hypothesis is that the percentage of participants achieving sustained virologic response in the BOC + PR group is superior to that in the Placebo (PBO) + PR group.
- Conditions
- Chronic Hepatitis C Genotype 1
- Being tested
- Boceprevir, Placebo, peginterferon alfa-2b, Ribavirin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BoceprevirDrug
Also called SCH 503034
boceprevir 200-mg capsules, 800 mg 3 times a day (TID), orally (PO)
PlaceboDrug
boceprevir-matched placebo four 200-mg capsules PO TID.
peginterferon alfa-2bBiological
Also called PegIntron
peginterferon alfa-2b 1.5 μg/kg/wk subcutaneously (SC)
RibavirinDrug
ribavirin (weight-based dosing) 800 to 1400 mg/day PO divided twice daily dose (BID).
| Study group | Role | What they receive |
|---|---|---|
| RGT BOC + PR | Experimental | Participants received PR for 4 weeks before addition of BOC. Participants then received response guided therapy (RGT) with BOC + PR for up to 32 weeks followed by PBO + PR for up to 20 weeks. Receives: Drug: Boceprevir; Biological: peginterferon alfa-2b; Drug: Ribavirin |
| PBO + PR (Control) | Placebo comparator | Participants received PR for 4 weeks before addition of BOC-matched PBO. Participants then received BOC + PR for up to 44 weeks. Receives: Drug: Placebo; Biological: peginterferon alfa-2b; Drug: Ribavirin |
| Crossover Arm | Experimental | Participants randomized to the PBO + PR Control arm who failed the futility rule at treatment week (TW) 12 or 24 were rolled over to the Crossover arm and received BOC + PR. Receives: Drug: Boceprevir; Biological: peginterferon alfa-2b; Drug: Ribavirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Achieving Sustained Virologic Response At Follow-up Week 24 (SVR24) Among Participants Who Received At Least One Dose of Any Trial Medication (Full Analysis Set Population)
SVR24 was defined as an undetectable plasma Hepatitis C Virus-ribonucleic acid (HCV-RNA) level at Follow-up Week 24 (FW24). If a participant was missing FW24 data and had undetectable HCV-RNA at FW12, the participant was considered a sustained virologic responder.
Measured: Follow-up Week 24 (up to 72 weeks)
Secondary outcomes (2)
Percentage of Participants Achieving SVR24 Among Participants Who Received At Least One Dose of Experimental Trial Drug (Modified Intent-To-Treat [mITT] Population)
SVR24 was defined as an undetectable plasma HCV-RNA level at FW24. If a participant was missing FW24 data and had undetectable HCV-RNA at FW12, the participant was considered a sustained virologic responder.
Measured: Follow-up Week 24 (up to 72 weeks)
Percentage of Participants Achieving Early Virologic Response (EVR) At Treatment Week (TW) 8
EVR was defined as an undetectable HCV-RNA level at TW 8. This analysis was conducted when all participants had completed 8 weeks of the study or had discontinued prior to TW 8.
Measured: Treatment Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2011 (estimated)
- Study start23 Nov 2011
- Primary completion21 Oct 2013
- Study completion21 Oct 2013
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Hepatitis C Genotype 1Studies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 238 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01425203
- Sponsor's protocol ID
- P08160
- Other IDs
- MK-3034-046
- Status last verified
- Jan 2021
- First submitted
- 26 Aug 2011
- Last updated
- 8 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Publications
Isakov V, Nikitin I, Chulanov V, Ogurtsov P, Lukyanova E, Long J, Wahl J, Helmond FA; P08160 Trial Investigators. Boceprevir plus peginterferon/ribavirin for treatment of chronic hepatitis C in Russia. World J Hepatol. 2016 Feb 28;8(6):331-9. doi: 10.4254/wjh.v8.i6.331.
PubMed 26962399
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Boceprevir in Combination With Peginterferon Alfa-2b Plus Ribavirin for Treatment of Chronic Hepatitis C Genotype 1 in Russia: Previously Untreated Patients and Patients Who Failed Prior Treatment With Pegylated-Interferon Plus Ribavirin
- ClinicalTrials.gov ID
- NCT01425203
- Acronym / sponsor ID
- P08160
- Conditions
- Chronic Hepatitis C Genotype 1
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 238 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 23 Nov 2011 (actual)
- Primary completion
- 21 Oct 2013 (actual)
- Study completion
- 21 Oct 2013 (actual)
- First posted
- 29 Aug 2011 (estimated)
- Results
- Posted 18 Aug 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether Boceprevir (BOC, SCH 503034, MK-3034) in combination with Peginterferon Alfa 2-b (PEG) plus Ribavirin (RBV) [PEG+RBV=PR] is effective in the treatment of chronic hepatitis C (CHC) genotype 1 among the Russian population. The primary hypothesis is that the percentage of participants achieving sustained virologic response in the BOC + PR group is superior to that in the Placebo (PBO) + PR group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| RGT BOC + PR | Experimental | Drug: Boceprevir, Biological: peginterferon alfa-2b, Drug: RibavirinParticipants received PR for 4 weeks before addition of BOC. Participants then received response guided therapy (RGT) with BOC + PR for up to 32 weeks followed by PBO + PR for up to 20 weeks. |
| PBO + PR (Control) | Placebo comparator | Drug: Placebo, Biological: peginterferon alfa-2b, Drug: RibavirinParticipants received PR for 4 weeks before addition of BOC-matched PBO. Participants then received BOC + PR for up to 44 weeks. |
| Crossover Arm | Experimental | Drug: Boceprevir, Biological: peginterferon alfa-2b, Drug: RibavirinParticipants randomized to the PBO + PR Control arm who failed the futility rule at treatment week (TW) 12 or 24 were rolled over to the Crossover arm and received BOC + PR. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- body weight ≥40 kg and ≤125 kg
- previously documented CHC genotype 1 infection;
- must have a liver biopsy with histology consistent with CHC and no other etiology
- if cirrhosis present, must have an ultrasound within 6 months of the screening visit (or between screening and Day 1) with no findings suspicious for hepatocellular carcinoma (HCC)
- agree to use acceptable methods of contraception with partner
Key exclusion criteria (8 listed)
- co-infected with the human immunodeficiency virus (HIV) or hepatitis B virus (Hepatitis B surface antigen [HBsAg] positive).
- required discontinuation of previous interferon or ribavirin regimen for an adverse event (possibly or probably related)
- treatment with ribavirin within 90 days and any interferon-alpha, based on the amendment, should be within 1 month prior to screening
- treatment with any investigational drug within 30 days of the screening visit in this trial
- evidence of decompensated liver disease including, but not limited to, a history or presence of clinical ascites, bleeding varices, or hepatic encephalopathy
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 |
|---|---|---|
| BoceprevirAlso: SCH 503034boceprevir 200-mg capsules, 800 mg 3 times a day (TID), orally (PO) | Drug | Crossover Arm, RGT BOC + PR |
| Placeboboceprevir-matched placebo four 200-mg capsules PO TID. | Drug | PBO + PR (Control) |
| peginterferon alfa-2bAlso: PegIntronpeginterferon alfa-2b 1.5 μg/kg/wk subcutaneously (SC) | Biological | Crossover Arm, PBO + PR (Control), RGT BOC + PR |
| Ribavirinribavirin (weight-based dosing) 800 to 1400 mg/day PO divided twice daily dose (BID). | Drug | Crossover Arm, PBO + PR (Control), RGT BOC + PR |
Primary outcome
Percentage of Participants Achieving Sustained Virologic Response At Follow-up Week 24 (SVR24) Among Participants Who Received At Least One Dose of Any Trial Medication (Full Analysis Set Population)
Time frame: Follow-up Week 24 (up to 72 weeks)
SVR24 was defined as an undetectable plasma Hepatitis C Virus-ribonucleic acid (HCV-RNA) level at Follow-up Week 24 (FW24). If a participant was missing FW24 data and had undetectable HCV-RNA at FW12, the participant was considered a sustained virologic responder.
2 secondary outcomes
Percentage of Participants Achieving SVR24 Among Participants Who Received At Least One Dose of Experimental Trial Drug (Modified Intent-To-Treat [mITT] Population)
Time frame: Follow-up Week 24 (up to 72 weeks)
Percentage of Participants Achieving Early Virologic Response (EVR) At Treatment Week (TW) 8
Time frame: Treatment Week 8
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 26962399Isakov V, Nikitin I, Chulanov V, Ogurtsov P, Lukyanova E, Long J, Wahl J, Helmond FA; P08160 Trial Investigators. Boceprevir plus peginterferon/ribavirin for treatment of chronic hepatitis C in Russia. World J Hepatol. 2016 Feb 28;8(6):331-9. doi: 10.4254/wjh.v8.i6.331.
- Individual participant dataSharing planned: Yes. http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
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.
Medical Director study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Boceprevir, peginterferon alfa-2b and Ribavirin in people with Chronic Hepatitis C Genotype 1, 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 6 inclusion and 8 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 8 Feb 2021. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 18 Aug 2014). 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?
Percentage of Participants Achieving Sustained Virologic Response At Follow-up Week 24 (SVR24) Among Participants Who Received At Least One Dose of Any Trial Medication (Full Analysis Set Population) (time frame: Follow-up Week 24 (up to 72 weeks)). 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 NCT01425203, which also lists 1 linked publication.
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 8 Feb 2021.