Chronic Hepatitis CPhase 3NCT01641666
Safety and Tolerability of Boceprevir in Combination With Peginterferon Alfa-2b Plus Ribavirin for the Treatment of Vietnamese Subjects With Chronic Hepatitis C Genotype 1 (P08599)
A Phase 3 study testing Boceprevir, Peginterferon Alfa-2b 1.5 mcg/kg/week and Ribavirin in people with Chronic Hepatitis C, run by Merck Sharp & Dohme LLC.
Trial summary
This study is designed to assess the safety and tolerability of boceprevir dosed 800 mg three times daily (TID) orally (PO) in combination with Peginterferon alfa-2b (PEG2b) 1.5 mcg/kg once a week (QW) administered subcutaneously (SC) plus ribavirin (RBV) (800 to 1400 mg/day) PO in Response Guided Therapy (RGT) in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Hepatitis C
- What is being tested?
- Boceprevir, Peginterferon Alfa-2b 1.5 mcg/kg/week and Ribavirin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- May 2014to Sep 2016
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- Weight ≥ 40 kg to ≤ 125 kg
- Sexually active male participants and female participants of child-bearing potential must agree to use a medically acceptable form of contraception
- Must have documented Chronic Hepatitis C Genotype 1 infection
- Must have failed prior treatment with interferon plus ribavirin
- Must have completed treatment with interferon plus ribavirin for at least 12 weeks
- Must have had a liver biopsy or Fibroscan to determine status as cirrhotic or non-cirrhotic
- Participants with cirrhosis must have had an ultrasound or imaging study within 6 months of the Screening visit
Who cannot join
- Known co-infection with the human immunodeficiency virus (HIV) or the hepatitis B virus
- Prior discontinuation of treatment with interferon or ribavirin due to the occurrence of an adverse event(s) considered by the investigator to be possibly or probably related to the treatment
- Treatment with ribavirin within 90 days and any interferon within 1 month of the Screening visit
- Treatment with any investigational drug within 30 days prior to the Screening visit
- Treatment with midazolam, pimozide, amiodarone, flecainide, propafenone, quinidine, or ergot derivatives within 2 weeks prior to the Day 1 visit
- Participation in any investigational trial within 30 days of the Screening visit
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- Evidence of decompensated liver disease
- Child Pugh score > 6 (Class B and C)
- Diabetic and/or hypertensive participants with clinically significant ocular examination findings
- Pre-existing psychiatric conditions
- Clinical diagnosis of substance abuse
- Active or suspected malignancy
- Pregnant or nursing
About this study
Official title: An Open-Label Study to Assess the Safety and Tolerability of Boceprevir in Combination With Peginterferon Alfa-2b Plus Ribavirin for Treatment of Vietnamese Subjects With Chronic Hepatitis C Genotype 1 Who Failed Prior Treatment With Any Interferon Plus Ribavirin in Vietnam
This study is designed to assess the safety and tolerability of boceprevir dosed 800 mg three times daily (TID) orally (PO) in combination with Peginterferon alfa-2b (PEG2b) 1.5 mcg/kg once a week (QW) administered subcutaneously (SC) plus ribavirin (RBV) (800 to 1400 mg/day) PO in Response Guided Therapy (RGT) in adult Vietnamese subjects with Chronic Hepatitis C, Genotype 1 (CHC GT1) who failed prior treatment with any interferon and ribavirin in Vietnam.
Read the detailed description
Each participant will participate in the trial for a maximum of 80 weeks from the time the participant signs the Informed Consent Form (ICF) through the final contact. After a Screening phase of approximately 4 to 8 weeks, each participant will receive treatment for approximately 36-48 weeks depending on response at Treatment Week 8.
A 4-week lead-in period with PEG2b plus RBV will be followed by 32 weeks boceprevir plus PEG2b/RBV. At treatment Week 36 participants will be assigned to the following treatments depending on the virologic response at Week 8 and cirrhotic status:
- For non-cirrhotic participants with undetectable hepatitis C virus (HCV)-RNA on Week 8, all treatment will be discontinued at Week 36.
- For non-cirrhotic participants with detectable HCV-RNA on Week 8, only boceprevir treatment will be discontinued at Week 36 and PEG2b and RBV treatment will continue to Week 48.
- For cirrhotic participants, the boceprevir plus PEG2b/RBV treatment will continue to Week 48.
The study has a futility rule at Week 12 at which point all subjects with detectable HCV-RNA levels will be discontinued. All participants will have a post-treatment follow-up period of at least 24 weeks.
- Conditions
- Chronic Hepatitis C
- Being tested
- Boceprevir, Peginterferon Alfa-2b 1.5 mcg/kg/week, Ribavirin
- 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.
BoceprevirDrug
Also called SCH 503034
Boceprevir will be dosed orally at a dose of 800 mg three times daily (TID) for a total daily dose of 2400 mg.
Peginterferon Alfa-2b 1.5 mcg/kg/weekDrug
Also called Pegintron®, Rebetol®
Peginterferon alpha-2b will be administered subcutaneously at a dose of 1.5 mcg/kg each week.
RibavirinDrug
Also called Rebetol®, Pegintron®
Ribavirin will be administered orally at a dose of 800 mg/day to 1400 mg/day in two divided daily doses (BID).
| Study group | Role | What they receive |
|---|---|---|
| Peg2b + Ribavirin + Boceprevir | Experimental | Peginterferon alpha-2b (Peg2b) plus ribavirin (RBV) starting on Day 1 and boceprevir starting on Week 5 Receives: Drug: Boceprevir; Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week; 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 (SVR)
Measured: Follow-Up Week 24
Percentage of Participants Experiencing a Serious Adverse Event (SAE) During the Study Therapy Period
Measured: Treatment Week 1 to Treatment Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2012 (estimated)
- Study startMay 2014
- Primary completionSep 2016 (estimated)
- Study completionSep 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01641666
- Sponsor's protocol ID
- P08599
- Status last verified
- Sep 2015
- First submitted
- 11 Jul 2012
- Last updated
- 9 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Study to Assess the Safety and Tolerability of Boceprevir in Combination With Peginterferon Alfa-2b Plus Ribavirin for Treatment of Vietnamese Subjects With Chronic Hepatitis C Genotype 1 Who Failed Prior Treatment With Any Interferon Plus Ribavirin in Vietnam
- ClinicalTrials.gov ID
- NCT01641666
- Acronym / sponsor ID
- P08599
- Conditions
- Chronic Hepatitis C
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- May 2014
- Primary completion
- Sep 2016 (estimated)
- Study completion
- Sep 2016 (estimated)
- First posted
- 17 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to assess the safety and tolerability of boceprevir dosed 800 mg three times daily (TID) orally (PO) in combination with Peginterferon alfa-2b (PEG2b) 1.5 mcg/kg once a week (QW) administered subcutaneously (SC) plus ribavirin (RBV) (800 to 1400 mg/day) PO in Response Guided Therapy (RGT) in adult Vietnamese subjects with Chronic Hepatitis C, Genotype 1 (CHC GT1) who failed prior treatment with any interferon and ribavirin in Vietnam.
Detailed description
Each participant will participate in the trial for a maximum of 80 weeks from the time the participant signs the Informed Consent Form (ICF) through the final contact. After a Screening phase of approximately 4 to 8 weeks, each participant will receive treatment for approximately 36-48 weeks depending on response at Treatment Week 8.
A 4-week lead-in period with PEG2b plus RBV will be followed by 32 weeks boceprevir plus PEG2b/RBV. At treatment Week 36 participants will be assigned to the following treatments depending on the virologic response at Week 8 and cirrhotic status:
- For non-cirrhotic participants with undetectable hepatitis C virus (HCV)-RNA on Week 8, all treatment will be discontinued at Week 36.
- For non-cirrhotic participants with detectable HCV-RNA on Week 8, only boceprevir treatment will be discontinued at Week 36 and PEG2b and RBV treatment will continue to Week 48.
- For cirrhotic participants, the boceprevir plus PEG2b/RBV treatment will continue to Week 48.
The study has a futility rule at Week 12 at which point all subjects with detectable HCV-RNA levels will be discontinued. All participants will have a post-treatment follow-up period of at least 24 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Peg2b + Ribavirin + Boceprevir | Experimental | Drug: Boceprevir, Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week, Drug: RibavirinPeginterferon alpha-2b (Peg2b) plus ribavirin (RBV) starting on Day 1 and boceprevir starting on Week 5 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Weight ≥ 40 kg to ≤ 125 kg
- Sexually active male participants and female participants of child-bearing potential must agree to use a medically acceptable form of contraception
- Must have documented Chronic Hepatitis C Genotype 1 infection
- Must have failed prior treatment with interferon plus ribavirin
- Must have completed treatment with interferon plus ribavirin for at least 12 weeks
Key exclusion criteria (13 listed)
- Known co-infection with the human immunodeficiency virus (HIV) or the hepatitis B virus
- Prior discontinuation of treatment with interferon or ribavirin due to the occurrence of an adverse event(s) considered by the investigator to be possibly or probably related to the treatment
- Treatment with ribavirin within 90 days and any interferon within 1 month of the Screening visit
- Treatment with any investigational drug within 30 days prior to the Screening visit
- Treatment with midazolam, pimozide, amiodarone, flecainide, propafenone, quinidine, or ergot derivatives within 2 weeks prior to the Day 1 visit
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 will be dosed orally at a dose of 800 mg three times daily (TID) for a total daily dose of 2400 mg. | Drug | Peg2b + Ribavirin + Boceprevir |
| Peginterferon Alfa-2b 1.5 mcg/kg/weekAlso: Pegintron®, Rebetol®Peginterferon alpha-2b will be administered subcutaneously at a dose of 1.5 mcg/kg each week. | Drug | Peg2b + Ribavirin + Boceprevir |
| RibavirinAlso: Rebetol®, Pegintron®Ribavirin will be administered orally at a dose of 800 mg/day to 1400 mg/day in two divided daily doses (BID). | Drug | Peg2b + Ribavirin + Boceprevir |
Primary outcome
Percentage of Participants Achieving Sustained Virologic Response (SVR)
Time frame: Follow-Up Week 24
Percentage of Participants Experiencing a Serious Adverse Event (SAE) During the Study Therapy Period
Time frame: Treatment Week 1 to Treatment Week 24
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2015.
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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 3 study testing Boceprevir, Peginterferon Alfa-2b 1.5 mcg/kg/week and Ribavirin 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 7 inclusion and 13 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: withdrawn, as of the sponsor's last update on 9 Sep 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 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?
The study was withdrawn before enrolling participants, so there are no results.
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 (SVR) (time frame: Follow-Up Week 24). 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?
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 9 Sep 2015.