Hepatitis C, ChronicPhase 3NCT01846832
A Study of TMC435 Plus Pegylated Interferon Alfa-2a and Ribavirin in Participants With Chronic HCV Infection
A Phase 3 study testing TMC435, Pegylated interferon alfa-2a (PegIFNα-2a) and Ribavirin (RBV) in people with Hepatitis C, Chronic and Infection, run by Janssen-Cilag International NV at 20 sites in 7 countries.
Trial summary
The purpose of this study is to evaluate the efficacy, tolerability, and safety of 12-weeks of treatment with TMC435 plus pegylated interferon alfa-2a (PegIFNα-2a) and ribavirin (RBV) in previously untreated adult participants with genotype 1 or genotype 4 chronic Hepatitis C Virus (HCV) infection. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hepatitis C, Chronic, Infection
- What is being tested?
- TMC435, Pegylated interferon alfa-2a (PegIFNα-2a) 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
- 232 participants
- Where
- 20 sitesin 7 countries
- Study dates
- Sep 2013to Aug 2015
- 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
- treatment-naïve with confirmed chronic Hepatitis C Virus (HCV) infection
- liver biopsy performed within 2 years prior to screening or non-invasive confirmation of the liver disease stage (by transient elastography) performed within 6 months prior to screening
- liver disease stage equivalent to Metavir Score F0-F2 (no fibrosis, or portal fibrosis without or with few septa)
Who cannot join
- -Participants with advanced liver disease equivalent to Metavir score F3-F4 (bridging fibrosis or cirrhosis), with hepatic decompensation, with any liver disease of non-HCV etiology, and/or with a non-genotype 1 or non-genotype 4 hepatitis C, hepatitis B or HIV co-infection will be excluded from the study
Trial locations and contacts
20 sites in 7 countries.
20 sites in 7 countries
Germany5 sites
Study site
Berlin
Study site
Düsseldorf
Study site
Frankfurt
Study site
Hamburg
Study site
Würzburg
France4 sites
Study site
Clichy
Study site
Limoges
Study site
Orléans
Study site
Saint-Laurent-du-Var
Spain4 sites
Study site
Barcelona
Study site
Madrid
Study site
Valencia
Study site
Valme
About this study
Official title: A Phase 3, Open-Label, Single-Arm Study to Evaluate the Safety and Efficacy of TMC435 Plus Pegylated Interferon Alfa-2a and Ribavirin Administered for 12 Weeks in Treatment-Naïve Subjects With Chronic Genotype 1 or Genotype 4 HCV Infection
The purpose of this study is to evaluate the efficacy, tolerability, and safety of 12-weeks of treatment with TMC435 plus pegylated interferon alfa-2a (PegIFNα-2a) and ribavirin (RBV) in previously untreated adult participants with genotype 1 or genotype 4 chronic Hepatitis C Virus (HCV) infection.
Read the detailed description
This is a multicenter, international study where all participants will receive triple therapy with the following 3 medications: TMC435 also referred to as simeprevir (formerly known as TMC435350) which is an investigational medication in development for the treatment of chronic hepatitis C virus (HCV) infection, pegylated interferon alfa-2a (PegIFNα-2a), and ribavirin (RBV). PegIFNα-2a and RBV are commercially available therapies for HCV infection. Participants will receive treatment with TMC435, PegIFNα-2a, and RBV for 12 weeks. If blood levels of HCV ribonucleic acid (RNA) monitored at Weeks 2, 4, and 8 are below 25 IU/mL, all treatment will be stopped at Week 12. If HCV RNA values are above 25 IU/mL at Weeks 2, 4, or 8, treatment with PegIFNα-2a and RBV will continue for an additional 12 weeks (up to Week 24) unless protocol-specified stopping criteria are met at Week 4 or 12, at which time all treatment will be discontinued. The study will be conducted in 3 phases: a screening phase of maximum 6 weeks, a treatment phase extending from Day 1 (baseline) up to 12 or 24 weeks depending on the response to treatment, and a posttreatment follow-up period of 24 weeks after the participant's last planned dose of study drug. The duration of the participation (excluding screening phase) for each participant will vary between 36 and 48 weeks, depending on the response to treatment. Blood samples for laboratory analysis will be obtained from participants at protocol-specified time points during the study and participant safety will be monitored throughout the study.
- Conditions
- Hepatitis C, Chronic, Infection
- Being tested
- TMC435, Pegylated interferon alfa-2a (PegIFNα-2a), Ribavirin (RBV)
- Keywords
- Hepatitis C, Chronic, Infection, Triple therapy, TMC435, simeprevir, Pegylated interferon alfa-2a (PegIFNα-2a), ribavirin (RBV), PEGASYS, COPEGUS
- Medical subject headings
- Hepatitis C, Chronic, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TMC435Drug
150 mg taken orally (by mouth) as a capsule with food once daily for 12 weeks.
Pegylated interferon alfa-2a (PegIFNα-2a)Drug
Also called Pegasys
180 mcg administered according to the manufacturer's prescribing information as a 0.5 mL subcutaneous (under the skin) (SC) injection once a week in the morning or evening for up to 24 weeks.
Ribavirin (RBV)Drug
Also called Copegus
1000 mg or 1200 mg administered according to the manufacturer's prescribing information for up to 24 weeks. If the participant's baseline body weight is < 75 kg, the total daily dose of RBV will be 1000 mg, administered orally (by mouth) as 400 mg (2 tablets of 200 mg, intake with food) in the morning and 600 mg (3 tablets of 200 mg, intake with food) in the evening. If the baseline body weight is > or = 75 kg, the total daily dose will be 1200 mg, administered as 600 mg in the morning and evening (3 tablets of 200 mg per intake, with food).
| Study group | Role | What they receive |
|---|---|---|
| TMC435 + PegIFNα-2a + RBV | Experimental | TMC435 will be administered as triple therapy with pegylated interferon alfa-2a (PegIFNα-2a) and ribavirin (RBV). Receives: Drug: TMC435; Drug: Pegylated interferon alfa-2a (PegIFNα-2a); Drug: Ribavirin (RBV) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion (percentage) of participants infected wtih genotype 1 HCV with a sustained virologic response 12 weeks after planned end of treatment (SVR12)
Participants are considered to have reached SVR12 if at the actual end of treatment hepatitis C virus (HCV) ribonucleic acid (RNA) levels < 25 IU/mL undetectable, AND at the time point of SVR12 (i.e., 12 weeks after the planned end of treatment [EOT]), HCV RNA levels < 25 IU/mL undetectable.
Measured: Week 24
Secondary outcomes (17)
The proportion (percentage) of participants infected wtih genotype 4 HCV with a sustained virologic response 12 weeks after planned end of treatment (SVR12)
See SVR12 defined above.
Measured: Week 24
The proportion (percentage) of participants who achieve rapid virologic response (RVR)
Rapid virologic response (RVR) defined as hepatitis C virus (HCV) ribonucleic acid (RNA) < 25 IU/mL undetectable measured 4 weeks after start of treatment. RVR will be assessed for all participants per assigned total treatment duration and per HCV genotype (separately).
Measured: Week 4
The proportion (percentage) of participants who achieve virologic response at Week 2 (W2VR)
Virologic response at Week 2 (W2VR) defined as hepatitis C virus (HCV) ribonucleic acid (RNA) < 25 IU/mL (detectable or undetectable) measured 2 weeks after start of treatment. W2VR will be assessed for all participants per assigned total treatment duration and per HCV genotype (separately).
Measured: Week 2
The proportion (percentage) of participants with sustained virologic response 24 weeks after planned end of treatment (SVR24)
Participants are considered to have reached SVR24 if at the actual end of treatment hepatitis C virus (HCV) ribonucleic acid (RNA) levels < 25 IU/mL undetectable, AND at the time point of SVR24 (i.e., 24 weeks after the planned end of treatment [EOT]) HCV RNA levels < 25 IU/mL undetectable. SVR24 will be assessed for all participants per assigned total treatment duration and per HCV genotype (separately).
Measured: Week 48
The proportion (percentage) of participants with sustained virologic response 12 weeks after planned end of treatment (SVR12)
SVR12 (defined above) will be assessed for all participants per assigned total treatment duration and per HCV genotype (separately).
Measured: Week 24
The proportion (percentage) of participants with > or = 2 log decrease in hepatitis C virus (HCV) RNA at each time point
To be assessed for all participants per assigned total treatment duration and per HCV genotype (separately).
Measured: Up to Week 48
The proportion (percentage) of participants with hepatitis C virus (HCV) RNA < 25 IU/mL undetectable at each time point
To be assessed for all participants per assigned total treatment duration and per HCV genotype (separately).
Measured: Up to Week 48
The proportion (percentage) of participants with viral breakthrough
Viral breakthrough is a confirmed increase of > 1 log10 IU/mL in hepatitis C virus (HCV) ribonucleic acid (RNA) level from the lowest level reached, or a confirmed HCV RNA level of > 100 IU/mL in participants whose HCV RNA levels had previously been below the limit of quantification (< 25 IU/mL detectable) or undetectable (< 25 IU/mL undetectable) while on study treatment. Viral breakthrough will be assessed for all participants per assigned total treatment duration and per HCV genotype (separately).
Measured: Up to Week 48
The proportion (percentage) of participants with viral relapse
Participants are considered to have a viral relapse if at actual end of treatment hepatitis C virus (HCV) ribonucleic acid (RNA) levels < 25 IU/mL undetectable, AND during the follow-up period HCV RNA levels > or = 25 IU/mL. Viral relapse will be assessed for all participants per assigned total treatment duration and per HCV genotype (separately).
Measured: Up to Week 48
Change from Baseline in the Hepatitis C Treatment Symptom & Impact Questionnaire (HCV SIQ) symptom and impact scores
The HCV SIQ asks participants to rate 26 symptoms associated with HCV or its treatment and how symptoms impacted the participants' life during the prior week. This questionnaire provides a simple tool for monitoring symptoms during HCV treatment and follow-up. To be assessed in participants with genotype 1 or genotype 4 HCV infection for both genotypes combined (subanalyses for each genotype separately will also be done).
Measured: Day 1 and at each study visit up to Week 48
Change from Baseline in The Fatigue Severity Scale (FSS) total score
The FSS will be used to document fatigue severity and impact of fatigue on participants' daily lives. To be assessed in participants with genotype 1 or genotype 4 HCV infection for both genotypes combined (subanalyses for each genotype separately will also be done).
Measured: Day 1 and at each study visit up to Week 48
Change from Baseline in The Center for Epidemiologic Studies Depression Scale (CES-D) score
The CES-D is a brief assessment that asks participants to rate how often in the past week they experienced 20 symptoms associated with depressive illness, will be used to assess depressive symptom severity. To be assessed in participants with genotype 1 or genotype 4 HCV infection for both genotypes combined (subanalyses for each genotype separately will also be done).
Measured: Day 1 and at each study visit up to Week 48
Change from Baseline in The Work Productivity and Activity Index (WPAI) for Hepatitis C missed work time, daily activity impairment, and productivity scores
The (WPAI) will be used to measure the impact of HCV on time missed from work (absenteeism), reduced performance while at work (productivity impairment), and impairment in daily activities without regard to employment status. To be assessed in participants with genotype 1 or genotype 4 HCV infection for both genotypes combined (subanalyses for each genotype separately will also be done).
Measured: Day 1 and at each study visit up to Week 48
Change from Baseline in The EuroQol 5 Dimension (EQ5D) Visual Analog Scale (VAS) valuation index, and Descriptive System scores
The EQ-5D questionnaire is an instrument designed to assess overall health status using 5 health dimension scores (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) and a "thermometer" visual analog scale (VAS) ranging from 0 (worst imaginable health state) to 100 (best imaginable health state). To be assessed in participants with genotype 1 or genotype 4 HCV infection for both genotypes combined (subanalyses for each genotype separately will also be done).
Measured: Day 1 and at each study visit up to Week 48
The proportion (percentage) of participants with normalized alanine aminotransferase (ALT) levels
To be assessed in participants with genotype 1 or genotype 4 HCV infection (separately by genotype)
Measured: Up to Week 48
Change from Screening in liver disease stage assessment
To be assessed in participants with genotype 1 or genotype 4 HCV infection (separately by genotype).
Measured: Week -6; Week 48
The number of participants reporting adverse events as a measure of safety and tolerability
All participants will be monitored throughout the study for the occurrence of adverse events including psychiatric symptoms, anemia, hyperglycemia (elevated glucose levels), disturbances in serum creatinine levels (a measure of renal [kidney] safety), decreased White Blood Cell (WBC) Count, decreased Platelet Count (ability of the blood to clot), and thyroid abnormalities.
Measured: Up to Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2013 (estimated)
- Study startSep 2013
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hepatitis C, ChronicStudies 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
- 232 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen-Cilag International NV
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- JJanssen-Cilag International NV Clinical Trial, Study director, Janssen-Cilag International NV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01846832
- Sponsor's protocol ID
- CR100981
- Other IDs
- TMC435HPC3014, 2012-004905-29
- Status last verified
- Sep 2016
- First submitted
- 1 May 2013
- Last updated
- 21 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Asselah T, Moreno C, Sarrazin C, Gschwantler M, Foster GR, Craxi A, Buggisch P, Sanai F, Bicer C, Lenz O, Van Dooren G, Nalpas C, Lonjon-Domanec I, Schlag M, Buti M. Efficacy of a 12-Week Simeprevir Plus Peginterferon/Ribavirin (PR) Regimen in Treatment-Naive Patients with Hepatitis C Virus (HCV) Genotype 4 (GT4) Infection and Mild-To-Moderate Fibrosis Displaying Early On-Treatment Virologic Response. PLoS One. 2017 Jan 5;12(1):e0168713. doi: 10.1371/journal.pone.0168713. eCollection 2017.
PubMed 28056030Asselah T, Moreno C, Sarrazin C, Gschwantler M, Foster GR, Craxi A, Buggisch P, Ryan R, Lenz O, Scott J, Van Dooren G, Lonjon-Domanec I, Schlag M, Buti M. An Open-Label Trial of 12-Week Simeprevir plus Peginterferon/Ribavirin (PR) in Treatment-Naive Patients with Hepatitis C Virus (HCV) Genotype 1 (GT1). PLoS One. 2016 Jul 18;11(7):e0158526. doi: 10.1371/journal.pone.0158526. eCollection 2016.
PubMed 27428331
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Open-Label, Single-Arm Study to Evaluate the Safety and Efficacy of TMC435 Plus Pegylated Interferon Alfa-2a and Ribavirin Administered for 12 Weeks in Treatment-Naïve Subjects With Chronic Genotype 1 or Genotype 4 HCV Infection
- ClinicalTrials.gov ID
- NCT01846832
- Acronym / sponsor ID
- CR100981
- Conditions
- Hepatitis C, Chronic, Infection
- Keywords
- Hepatitis C, Chronic, Infection, Triple therapy, TMC435, simeprevir, Pegylated interferon alfa-2a (PegIFNα-2a), ribavirin (RBV), PEGASYS
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 232 participants (actual)
- Lead sponsor
- Janssen-Cilag International NVIndustry (pharma, biotech, devices)
- Study start
- Sep 2013
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 3 May 2013 (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 efficacy, tolerability, and safety of 12-weeks of treatment with TMC435 plus pegylated interferon alfa-2a (PegIFNα-2a) and ribavirin (RBV) in previously untreated adult participants with genotype 1 or genotype 4 chronic Hepatitis C Virus (HCV) infection.
Detailed description
This is a multicenter, international study where all participants will receive triple therapy with the following 3 medications: TMC435 also referred to as simeprevir (formerly known as TMC435350) which is an investigational medication in development for the treatment of chronic hepatitis C virus (HCV) infection, pegylated interferon alfa-2a (PegIFNα-2a), and ribavirin (RBV). PegIFNα-2a and RBV are commercially available therapies for HCV infection. Participants will receive treatment with TMC435, PegIFNα-2a, and RBV for 12 weeks. If blood levels of HCV ribonucleic acid (RNA) monitored at Weeks 2, 4, and 8 are below 25 IU/mL, all treatment will be stopped at Week 12. If HCV RNA values are above 25 IU/mL at Weeks 2, 4, or 8, treatment with PegIFNα-2a and RBV will continue for an additional 12 weeks (up to Week 24) unless protocol-specified stopping criteria are met at Week 4 or 12, at which time all treatment will be discontinued. The study will be conducted in 3 phases: a screening phase of maximum 6 weeks, a treatment phase extending from Day 1 (baseline) up to 12 or 24 weeks depending on the response to treatment, and a posttreatment follow-up period of 24 weeks after the participant's last planned dose of study drug. The duration of the participation (excluding screening phase) for each participant will vary between 36 and 48 weeks, depending on the response to treatment. Blood samples for laboratory analysis will be obtained from participants at protocol-specified time points during the study and participant safety will be monitored throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TMC435 + PegIFNα-2a + RBV | Experimental | Drug: TMC435, Drug: Pegylated interferon alfa-2a (PegIFNα-2a), Drug: Ribavirin (RBV)TMC435 will be administered as triple therapy with pegylated interferon alfa-2a (PegIFNα-2a) and ribavirin (RBV). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- treatment-naïve with confirmed chronic Hepatitis C Virus (HCV) infection
- liver biopsy performed within 2 years prior to screening or non-invasive confirmation of the liver disease stage (by transient elastography) performed within 6 months prior to screening
- liver disease stage equivalent to Metavir Score F0-F2 (no fibrosis, or portal fibrosis without or with few septa)
Key exclusion criteria (1 listed)
- -Participants with advanced liver disease equivalent to Metavir score F3-F4 (bridging fibrosis or cirrhosis), with hepatic decompensation, with any liver disease of non-HCV etiology, and/or with a non-genotype 1 or non-genotype 4 hepatitis C, hepatitis B or HIV co-infection will be excluded from the study
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 |
|---|---|---|
| TMC435150 mg taken orally (by mouth) as a capsule with food once daily for 12 weeks. | Drug | TMC435 + PegIFNα-2a + RBV |
| Pegylated interferon alfa-2a (PegIFNα-2a)Also: Pegasys180 mcg administered according to the manufacturer's prescribing information as a 0.5 mL subcutaneous (under the skin) (SC) injection once a week in the morning or evening for up to 24 weeks. | Drug | TMC435 + PegIFNα-2a + RBV |
| Ribavirin (RBV)Also: Copegus1000 mg or 1200 mg administered according to the manufacturer's prescribing information for up to 24 weeks. If the participant's baseline body weight is < 75 kg, the total daily dose of RBV will be 1000 mg, administered orally (by mouth) as 400 mg (2 tablets of 200 mg, intake with food) in the morning and 600 mg (3 tablets of 200 mg, intake with food) in the evening. If the baseline body weight is > or = 75 kg, the total daily dose will be 1200 mg, administered as 600 mg in the morning and evening (3 tablets of 200 mg per intake, with food). | Drug | TMC435 + PegIFNα-2a + RBV |
Primary outcome
The proportion (percentage) of participants infected wtih genotype 1 HCV with a sustained virologic response 12 weeks after planned end of treatment (SVR12)
Time frame: Week 24
Participants are considered to have reached SVR12 if at the actual end of treatment hepatitis C virus (HCV) ribonucleic acid (RNA) levels < 25 IU/mL undetectable, AND at the time point of SVR12 (i.e., 12 weeks after the planned end of treatment [EOT]), HCV RNA levels < 25 IU/mL undetectable.
17 secondary outcomes
The proportion (percentage) of participants infected wtih genotype 4 HCV with a sustained virologic response 12 weeks after planned end of treatment (SVR12)
Time frame: Week 24
The proportion (percentage) of participants who achieve rapid virologic response (RVR)
Time frame: Week 4
The proportion (percentage) of participants who achieve virologic response at Week 2 (W2VR)
Time frame: Week 2
The proportion (percentage) of participants with sustained virologic response 24 weeks after planned end of treatment (SVR24)
Time frame: Week 48
The proportion (percentage) of participants with sustained virologic response 12 weeks after planned end of treatment (SVR12)
Time frame: Week 24
The proportion (percentage) of participants with > or = 2 log decrease in hepatitis C virus (HCV) RNA at each time point
Time frame: Up to Week 48
The proportion (percentage) of participants with hepatitis C virus (HCV) RNA < 25 IU/mL undetectable at each time point
Time frame: Up to Week 48
The proportion (percentage) of participants with viral breakthrough
Time frame: Up to Week 48
The proportion (percentage) of participants with viral relapse
Time frame: Up to Week 48
Change from Baseline in the Hepatitis C Treatment Symptom & Impact Questionnaire (HCV SIQ) symptom and impact scores
Time frame: Day 1 and at each study visit up to Week 48
Change from Baseline in The Fatigue Severity Scale (FSS) total score
Time frame: Day 1 and at each study visit up to Week 48
Change from Baseline in The Center for Epidemiologic Studies Depression Scale (CES-D) score
Time frame: Day 1 and at each study visit up to Week 48
Change from Baseline in The Work Productivity and Activity Index (WPAI) for Hepatitis C missed work time, daily activity impairment, and productivity scores
Time frame: Day 1 and at each study visit up to Week 48
Change from Baseline in The EuroQol 5 Dimension (EQ5D) Visual Analog Scale (VAS) valuation index, and Descriptive System scores
Time frame: Day 1 and at each study visit up to Week 48
The proportion (percentage) of participants with normalized alanine aminotransferase (ALT) levels
Time frame: Up to Week 48
Change from Screening in liver disease stage assessment
Time frame: Week -6; Week 48
The number of participants reporting adverse events as a measure of safety and tolerability
Time frame: Up to Week 48
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 21 Sep 2016.
- Derived from this study: PubMed 28056030Asselah T, Moreno C, Sarrazin C, Gschwantler M, Foster GR, Craxi A, Buggisch P, Sanai F, Bicer C, Lenz O, Van Dooren G, Nalpas C, Lonjon-Domanec I, Schlag M, Buti M. Efficacy of a 12-Week Simeprevir Plus Peginterferon/Ribavirin (PR) Regimen in Treatment-Naive Patients with Hepatitis C Virus (HCV) Genotype 4 (GT4) Infection and Mild-To-Moderate Fibrosis Displaying Early On-Treatment Virologic Response. PLoS One. 2017 Jan 5;12(1):e0168713. doi: 10.1371/journal.pone.0168713. eCollection 2017.
- Derived from this study: PubMed 27428331Asselah T, Moreno C, Sarrazin C, Gschwantler M, Foster GR, Craxi A, Buggisch P, Ryan R, Lenz O, Scott J, Van Dooren G, Lonjon-Domanec I, Schlag M, Buti M. An Open-Label Trial of 12-Week Simeprevir plus Peginterferon/Ribavirin (PR) in Treatment-Naive Patients with Hepatitis C Virus (HCV) Genotype 1 (GT1). PLoS One. 2016 Jul 18;11(7):e0158526. doi: 10.1371/journal.pone.0158526. eCollection 2016.
- A Phase 3, Open-Label Study to Evaluate the Safety and Efficacy of TMC435 plus Pegylated Interferon alfa-2a and Ribavirin Administered for 12 Weeks in Treatment-Naïve Subjects with Chronic Genotype 1 or Genotype 4 HCV InfectionLink provided by the sponsor.
Related trials for Hepatitis C, Chronic
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
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.
JJanssen-Cilag International NV Clinical Trial study director
Janssen-Cilag International NV
20 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing TMC435, Pegylated interferon alfa-2a (PegIFNα-2a) and Ribavirin (RBV) in people with Hepatitis C, Chronic and Infection, run by Janssen-Cilag International NV at 20 sites in 7 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 3 inclusion and 1 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 21 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Germany, France, Spain, Austria, Belgium and 2 more countries. 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?
The proportion (percentage) of participants infected wtih genotype 1 HCV with a sustained virologic response 12 weeks after planned end of treatment (SVR12) (time frame: Week 24). 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 NCT01846832, which also lists 2 linked publications.
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 21 Sep 2016.