Chronic Hepatitis C Virus (HCV) InfectionPhase 3REPLACENCT01571583
An Efficacy and Safety Study of Telaprevir in Patients With Genotype 1 Hepatitis C Infection After Liver Transplantation
A Phase 3 study testing Telaprevir, Pegylated interferon alfa-2a and Ribavirin in people with Chronic Hepatitis C Virus (HCV) Infection, run by Janssen-Cilag International NV at 21 sites in 6 countries.
Trial summary
The purpose of this study is to evaluate the effectiveness of telaprevir in combination with Peg-IFN-alfa-2a and ribavirin in stable liver transplant patients with chronic hepatitis C virus (HCV) genotype 1. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Hepatitis C Virus (HCV) Infection
- What is being tested?
- Telaprevir, Pegylated interferon alfa-2a 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
- 74 participants
- Where
- 21 sitesin 6 countries
- Study dates
- Feb 2012to Jul 2014
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- First time liver transplant recipient whose primary pre-transplant diagnosis was chronic hepatitis C genotype 1
- More than 6 months to 10 years post-liver transplant
- Patient did or did not receive treatment for HCV prior to liver transplantation
- Patient must agree to have a liver graft biopsy during the screening period unless they had a biopsy within three months of the screening period (for patients between 6 months and one year post transplant) or within six months of the screening period (for patients who are more than one year post transplant)
- A female patient of childbearing potential and a nonvasectomized male patient who has a female partner of childbearing potential must agree to the use of 2 effective methods of birth control from screening until 6 months (female patient) or 7 months (male patient) after the last dose of ribavirin
Who cannot join
- Patient is currently infected or co-infected with HCV of another genotype than genotype 1
- Patient received treatment for hepatitis C following liver transplantation
- Patient has history of decompensated liver disease or shows evidence of significant liver disease in addition to hepatitis C
- Patient with human immunodeficiency virus or hepatitis B virus co-infection
- Patient with active malignant disease or history of malignant disease within the past 5 years (with the exception of treated basal cell carcinoma or hepatocellular carcinoma)
Trial locations and contacts
21 sites in 6 countries.
21 sites in 6 countries
France5 sites
Study site
Clichy
Study site
Marseille
Study site
Montpellier
Study site
Rennes Cedex N/A
Study site
Villejuif
Germany5 sites
Study site
Essen
Study site
Frankfurt A. M.
Study site
Hanover
Study site
Leipzig
Study site
Münster
Belgium4 sites
Study site
Brussels
Study site
Ghent
Study site
Leuven
Study site
Liège
About this study
Official title: Open-Label, Phase 3b Study To Determine Efficacy and Safety of Telaprevir, Pegylated-Interferon-alfa-2a and Ribavirin in Hepatitis C Genotype 1 Infected, Stable Liver Transplant Subjects
The purpose of this study is to evaluate the effectiveness of telaprevir in combination with Peg-IFN-alfa-2a and ribavirin in stable liver transplant patients with chronic hepatitis C virus (HCV) genotype 1.
Read the detailed description
This is an open-label (all people know the identity of the intervention), multicenter study in genotype 1 chronic HCV infected liver transplant patients who will be treated for 12 weeks with telaprevir 750 mg every 8 hours given in combination with Peg-IFN-alfa-2a and ribavirin followed by 36 weeks of treatment with Peg-IFN-alfa-2a and ribavirin alone. The total treatment duration will be 48 weeks. Safety will be evaluated throughout the study and will include evaluations of adverse events, clinical laboratory tests, electrocardiogram, vital signs, and physical examination.
- Being tested
- Telaprevir, Pegylated interferon alfa-2a, Ribavirin
- Keywords
- Chronic HCV infection, Genotype 1 chronic HCV, Liver transplantation, Hepatitis C, Hep C, HCV, Telaprevir, Pegylated-Interferon-alfa-2a, Ribavirin
- Medical subject headings
- Hepatitis C, Chronic, Hepatitis C, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelaprevirDrug
Type=exact number, unit=mg, number=375, form=tablet, route=oral. Patients will receive 2 oral tablets (750 mg) every 8 hours for 12 weeks.
Pegylated interferon alfa-2aDrug
Type=exact number, unit=µg, number=180, form=injection, route=subcutaneous. 180 microgram (µg) per week, subcutaneous injection, for 48 weeks.
RibavirinDrug
Type=exact number, unit=mg, number=200, form=tablet, route=oral. Starting from 600 mg (3 tablets) per day on Day 1. This dose will become higher or lower based on blood results and the investigators opinion (to a goal of 1000 to 1200 mg/day [5 to 6 tablets] based on subject weight), twice daily regimen, for 48 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Telaprevir+Peg-IFN-alfa-2a+Ribavirin | Experimental | Patients will be treated for 12 weeks with telaprevir in combination with Pegylated interferon alfa-2a (Peg-IFN-alfa-2a) and ribavirin followed by 36 weeks of treatment with Peg-IFN-alfa-2a and ribavirin alone. Receives: Drug: Telaprevir; Drug: Pegylated interferon alfa-2a; Drug: Ribavirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients achieving sustained virologic response (SVR) 12 planned
SVR12 planned is defined as having plasma hepatitis C virus (HCV ) ribonucleic acid (RNA) level less than 25 IU/mL 12 weeks after the last planned dose of study medication.
Measured: Week 60
Secondary outcomes (17)
Number of patients achieving SVR12 planned(c)
SVR12 planned(c) is defined as having undetectable plasma HCV RNA levels 12 weeks after the last planned dose of study drugs.
Measured: Week 60
Number of patients achieving SVR24 planned
SVR24 planned is defined as having plasma HCV RNA levels less than 25 IU/mL 24 weeks after the last planned dose of study medication.
Measured: Week 72
Number of patients achieving SVR24 planned(c)
SVR24 planned(c) is defined as having an undetectable plasma HCV RNA level 24 weeks after the last planned dose of study medication.
Measured: Week 72
Number of patients having an undetectable HCV RNA level at Week 4 of treatment
Measured: Week 4
Number of patients having an undetectable HCV RNA level at Week 12 of treatment
Measured: Week 12
Number of patients having undetectable HCV RNA levels at Week 4 and Week 12 of treatment
Measured: Week 4 and Week 12
Number of patients having an undetectable HCV RNA level at the actual end of treatment
Measured: Week 48
Number of patients having an undetectable HCV RNA level at the planned end of treatment
Measured: Week 48
Number of patients having less than 25 IU/mL at the planned end of treatment
Measured: Week 48
Number of patients with on-treatment virologic failure
Virologic failure is defined as patients who meet a virologic stopping rule and/or meet the definition of viral breakthrough.
Measured: Week 48
Number of patients with relapse after undetectable HCV RNA at actual end of treatment
Number of patients who relapse, defined as having confirmed detectable HCV RNA during the follow-up period after previous undetectable HCV RNA (less than 25 IU/mL, target not detected) at actual end of treatment.
Measured: Week 48
Number of patients with relapse after undetectable HCV RNA at planned end of treatment
Number of patients who relapse, defined as having confirmed detectable HCV RNA during the follow-up period after previous undetectable HCV RNA (less than 25 IU/mL, target not detected) at planned end of treatment.
Measured: Week 48
Number of patients with relapse after previous HCV RNA less than 25 IU/mL at planned end of treatment
Number of patients who relapse, defined as having confirmed detectable HCV RNA during the follow-up period after previous HCV RNA less than 25 IU/mL at planned end of treatment.
Measured: Week 48
Number of patients with viral breakthrough
Number of patients with viral breakthrough (defined as an increase more than 1 log in HCV RNA level from the lowest level reached, or a value of HCV RNA more than 100 IU/mL in patients whose HCV RNA has previously become less than 25 IU/mL during treatment).
Measured: Week 48
Change from baseline in log HCV RNA values
Change from baseline in log HCV RNA values at each time point during treatment.
Measured: Up to Week 52
Number of patients who have changes in liver graft biopsy histology
Measured: Up to Week 72
Number of patients with adverse events
Measured: Up to Week 72
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2012 (estimated)
- Study startFeb 2012
- Primary completionApr 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis C Virus (HCV) InfectionStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen-Cilag International NV
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen-Cilag International NV, Belgium Clinical Trial, Study director, Janssen-Cilag International NV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01571583
- Sponsor's protocol ID
- CR018721
- Other IDs
- VX-950HPC3006, 2011-004724-35
- Acronym
- REPLACE
- Status last verified
- Jun 2016
- First submitted
- 16 Dec 2011
- Last updated
- 30 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label, Phase 3b Study To Determine Efficacy and Safety of Telaprevir, Pegylated-Interferon-alfa-2a and Ribavirin in Hepatitis C Genotype 1 Infected, Stable Liver Transplant Subjects
- ClinicalTrials.gov ID
- NCT01571583
- Acronym / sponsor ID
- REPLACE / CR018721
- Keywords
- Chronic HCV infection, Genotype 1 chronic HCV, Liver transplantation, Hepatitis C, Hep C, HCV, Telaprevir, Pegylated-Interferon-alfa-2a
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Janssen-Cilag International NVIndustry (pharma, biotech, devices)
- Study start
- Feb 2012
- Primary completion
- Apr 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 5 Apr 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.
The purpose of this study is to evaluate the effectiveness of telaprevir in combination with Peg-IFN-alfa-2a and ribavirin in stable liver transplant patients with chronic hepatitis C virus (HCV) genotype 1.
Detailed description
This is an open-label (all people know the identity of the intervention), multicenter study in genotype 1 chronic HCV infected liver transplant patients who will be treated for 12 weeks with telaprevir 750 mg every 8 hours given in combination with Peg-IFN-alfa-2a and ribavirin followed by 36 weeks of treatment with Peg-IFN-alfa-2a and ribavirin alone. The total treatment duration will be 48 weeks. Safety will be evaluated throughout the study and will include evaluations of adverse events, clinical laboratory tests, electrocardiogram, vital signs, and physical examination.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Telaprevir+Peg-IFN-alfa-2a+Ribavirin | Experimental | Drug: Telaprevir, Drug: Pegylated interferon alfa-2a, Drug: RibavirinPatients will be treated for 12 weeks with telaprevir in combination with Pegylated interferon alfa-2a (Peg-IFN-alfa-2a) and ribavirin followed by 36 weeks of treatment with Peg-IFN-alfa-2a and ribavirin alone. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- First time liver transplant recipient whose primary pre-transplant diagnosis was chronic hepatitis C genotype 1
- More than 6 months to 10 years post-liver transplant
- Patient did or did not receive treatment for HCV prior to liver transplantation
- Patient must agree to have a liver graft biopsy during the screening period unless they had a biopsy within three months of the screening period (for patients between 6 months and one year post transplant) or within six months of the screening period (for patients who are more than one year post transplant)
- A female patient of childbearing potential and a nonvasectomized male patient who has a female partner of childbearing potential must agree to the use of 2 effective methods of birth control from screening until 6 months (female patient) or 7 months (male patient) after the last dose of ribavirin
Key exclusion criteria (5 listed)
- Patient is currently infected or co-infected with HCV of another genotype than genotype 1
- Patient received treatment for hepatitis C following liver transplantation
- Patient has history of decompensated liver disease or shows evidence of significant liver disease in addition to hepatitis C
- Patient with human immunodeficiency virus or hepatitis B virus co-infection
- Patient with active malignant disease or history of malignant disease within the past 5 years (with the exception of treated basal cell carcinoma or hepatocellular carcinoma)
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 |
|---|---|---|
| TelaprevirType=exact number, unit=mg, number=375, form=tablet, route=oral. Patients will receive 2 oral tablets (750 mg) every 8 hours for 12 weeks. | Drug | Telaprevir+Peg-IFN-alfa-2a+Ribavirin |
| Pegylated interferon alfa-2aType=exact number, unit=µg, number=180, form=injection, route=subcutaneous. 180 microgram (µg) per week, subcutaneous injection, for 48 weeks. | Drug | Telaprevir+Peg-IFN-alfa-2a+Ribavirin |
| RibavirinType=exact number, unit=mg, number=200, form=tablet, route=oral. Starting from 600 mg (3 tablets) per day on Day 1. This dose will become higher or lower based on blood results and the investigators opinion (to a goal of 1000 to 1200 mg/day [5 to 6 tablets] based on subject weight), twice daily regimen, for 48 weeks. | Drug | Telaprevir+Peg-IFN-alfa-2a+Ribavirin |
Primary outcome
Number of patients achieving sustained virologic response (SVR) 12 planned
Time frame: Week 60
SVR12 planned is defined as having plasma hepatitis C virus (HCV ) ribonucleic acid (RNA) level less than 25 IU/mL 12 weeks after the last planned dose of study medication.
17 secondary outcomes
Number of patients achieving SVR12 planned(c)
Time frame: Week 60
Number of patients achieving SVR24 planned
Time frame: Week 72
Number of patients achieving SVR24 planned(c)
Time frame: Week 72
Number of patients having an undetectable HCV RNA level at Week 4 of treatment
Time frame: Week 4
Number of patients having an undetectable HCV RNA level at Week 12 of treatment
Time frame: Week 12
Number of patients having undetectable HCV RNA levels at Week 4 and Week 12 of treatment
Time frame: Week 4 and Week 12
Number of patients having an undetectable HCV RNA level at the actual end of treatment
Time frame: Week 48
Number of patients having an undetectable HCV RNA level at the planned end of treatment
Time frame: Week 48
Number of patients having less than 25 IU/mL at the planned end of treatment
Time frame: Week 48
Number of patients with on-treatment virologic failure
Time frame: Week 48
Number of patients with relapse after undetectable HCV RNA at actual end of treatment
Time frame: Week 48
Number of patients with relapse after undetectable HCV RNA at planned end of treatment
Time frame: Week 48
Number of patients with relapse after previous HCV RNA less than 25 IU/mL at planned end of treatment
Time frame: Week 48
Number of patients with viral breakthrough
Time frame: Week 48
Change from baseline in log HCV RNA values
Time frame: Up to Week 52
Number of patients who have changes in liver graft biopsy histology
Time frame: Up to Week 72
Number of patients with adverse events
Time frame: Up to Week 72
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2016.
- Open-Label, Phase 3b Study To Determine Efficacy and Safety of Telaprevir, Pegylated-Interferon-alfa-2a and Ribavirin in Hepatitis C Genotype 1 Infected, Stable Liver Transplant Subjects(18137).Link provided by the sponsor.
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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.
Janssen-Cilag International NV, Belgium Clinical Trial study director
Janssen-Cilag International NV
21 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Telaprevir, Pegylated interferon alfa-2a and Ribavirin in people with Chronic Hepatitis C Virus (HCV) Infection, run by Janssen-Cilag International NV at 21 sites in 6 countries.
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 5 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 30 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in France, Germany, Belgium, Spain, Austria and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of patients achieving sustained virologic response (SVR) 12 planned (time frame: Week 60). 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 30 Jun 2016.