MedDataX Logo

An Efficacy, Safety and Tolerability Study of TMC435 in Genotype 1 Hepatitis C-infected Patients Who Relapsed After Previous Therapy

NCT ID: NCT01281839

Last Updated: 2014-04-23

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

394 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2013-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to investigate the effectiveness and safety of TMC435 compared with placebo in patients who are infected with genotype 1 hepatitis C virus who relapsed after previous interferon-based therapy. Patients will also receive peginterferon alfa-2a and ribavirin as part of their treatment.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

An Efficacy, Safety, and Tolerability Study of TMC435 in Treatment-naive, Genotype 1 Hepatitis C-infected Patients

NCT01289782

Hepatitis C
COMPLETED PHASE3

An Efficacy, Safety, and Tolerability Study of TMC435 in Treatment-naive, Genotype 1 Hepatitis C-infected Participants

NCT01290679

Hepatitis C
COMPLETED PHASE3

An Efficacy, Pharmacokinetics, Safety and Tolerability Study of TMC435 as Part of a Treatment Regimen for Hepatitis C-Infected Patients

NCT01725529

Hepatitis C, Chronic
COMPLETED PHASE3

A Study of TMC435 in Genotype 1, Hepatitis C-infected Patients Who Relapsed After Previous Interferon (IFN)-Based Therapy

NCT01290731

Hepatitis C, Chronic
COMPLETED PHASE3

A Phase III Study of TMC435 in Treatment-naive, Genotype 1, Hepatitis C-infected Patients

NCT01292239

Hepatitis C, Chronic
COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This is a randomized, double-blind (neither physician nor patients knows the name of the assigned drug), placebo-controlled study of TMC435 in patients who are infected with genotype 1 hepatitis C virus who relapsed after previous interferon-based therapy. Patients in this study will also receive two other drugs for their infection called peginterferon alfa-2a and ribavirin. The purpose of the study is to investigate if TMC435 is superior to placebo in reducing hepatitis C virus to an undetectable level 24 weeks after the end of treatment. For the first 12 weeks, patients will take TMC435 or placebo, plus peginterferon alfa-2a and ribavirin. For the next 12 weeks, patients will take peginterferon alfa-2a and ribavirin only. After that, some patients will continue to take peginterferon alfa-2a and ribavirin for up to 24 additional weeks. Other patients will stop taking peginterferon alfa-2a and ribavirin. The study doctor will inform each patient about how to take their study medication and when they should stop taking it. After a patient stops taking study medication, they will continue to come to the doctor's office for study visits until a total of 72 weeks after they enroll in the study. The total duration of the study is 78 weeks (including screening). Patients will be monitored for safety throughout the study. Study assessments at each study visit may include but are not limited to: blood and urine collection for testing, ECG assessments (a measurement of the electrical activity of your heart), patient questionnaires, and physical examinations TMC435 will be taken as an oral capsule of 150 mg once per day. Peginterferon (Pegasys ®) will be given as an injection of 180 µg once each week. Ribavirin (Copegus ®) will be taken as a tablet twice each day and the dose will depend on your body weight.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hepatitis C

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

TMC435

TMC435 150 mg capsule once daily for 12 weeks in addition to peginterferon alfa-2a and ribavirin for 24 or 48 weeks

Group Type EXPERIMENTAL

TMC435

Intervention Type DRUG

150 mg capsule once daily for 12 weeks in addition to peginterferon alfa-2a and ribavirin for 24 or 48 weeks

Peginterferon alpha-2a (PegIFN alpha-2a)

Intervention Type DRUG

One subcutaneous (under the skin) injection containing 0.5 mL solution with 180 mcg PegIFN alpha-2a once weekly for up to 48 weeks.

Ribavirin (RBV)

Intervention Type DRUG

200-mg tablets of RBV (body-weight adjusted dose) taken orally (by mouth) twice daily for up to 48 weeks.

Placebo

Placebo 150 mg capsule once daily for 12 weeks in addition to peginterferon alfa-2a and ribavirin for 48 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

150 mg capsule once daily for 12 weeks in addition to peginterferon alfa-2a and ribavirin for 48 weeks

Peginterferon alpha-2a (PegIFN alpha-2a)

Intervention Type DRUG

One subcutaneous (under the skin) injection containing 0.5 mL solution with 180 mcg PegIFN alpha-2a once weekly for up to 48 weeks.

Ribavirin (RBV)

Intervention Type DRUG

200-mg tablets of RBV (body-weight adjusted dose) taken orally (by mouth) twice daily for up to 48 weeks.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

TMC435

150 mg capsule once daily for 12 weeks in addition to peginterferon alfa-2a and ribavirin for 24 or 48 weeks

Intervention Type DRUG

Placebo

150 mg capsule once daily for 12 weeks in addition to peginterferon alfa-2a and ribavirin for 48 weeks

Intervention Type DRUG

Peginterferon alpha-2a (PegIFN alpha-2a)

One subcutaneous (under the skin) injection containing 0.5 mL solution with 180 mcg PegIFN alpha-2a once weekly for up to 48 weeks.

Intervention Type DRUG

Ribavirin (RBV)

200-mg tablets of RBV (body-weight adjusted dose) taken orally (by mouth) twice daily for up to 48 weeks.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Pegasys Copegus

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Genotype 1 hepatitis C infection (confirmed at screening)
* Have previously received peginterferon-based therapy for at least 24 weeks with documented HCV RNA at last measurement and relapsed within 1 year of last taking medication
* Liver biopsy within 3 years before screening (or between the screening and baseline visit) showing chronic hepatitis C infection
* Must agree to use 2 forms of effective contraception throughout study (both males and females)

Exclusion Criteria

* Infection with HIV or non-genotype 1 hepatitis C
* Liver disease not related to hepatitic C infection
* Hepatic decompensation
* Significant laboratory abnormalities or other active diseases
* Pregnant or planning to become pregnant
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Janssen R&D Ireland

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Janssen R&D Ireland Clinical Trial

Role: STUDY_DIRECTOR

Janssen R&D Ireland

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Bakersfield, California, United States

Site Status

Aurora, Colorado, United States

Site Status

Jacksonville, Florida, United States

Site Status

Orlando, Florida, United States

Site Status

Atlanta, Georgia, United States

Site Status

Crestview Hills, Kentucky, United States

Site Status

Saint Paul, Minnesota, United States

Site Status

Jackson, Mississippi, United States

Site Status

Germantown, Tennessee, United States

Site Status

Houston, Texas, United States

Site Status

San Antonio, Texas, United States

Site Status

Adelaide, , Australia

Site Status

Kingswood, , Australia

Site Status

Melbourne, , Australia

Site Status

Sydney, , Australia

Site Status

Woolloongabba, , Australia

Site Status

Vienna, , Austria

Site Status

Antwerp, , Belgium

Site Status

Bruges, , Belgium

Site Status

Brussels, , Belgium

Site Status

Ghent, , Belgium

Site Status

Leuven, , Belgium

Site Status

Vancouver, British Columbia, Canada

Site Status

Ottawa, Ontario, Canada

Site Status

Toronto, Ontario, Canada

Site Status

Montreal, Quebec, Canada

Site Status

Créteil, , France

Site Status

Grenoble, , France

Site Status

Lyon, , France

Site Status

Nice, , France

Site Status

Paris, , France

Site Status

Rennes, , France

Site Status

Vandœuvre-lès-Nancy, , France

Site Status

Berlin, , Germany

Site Status

Düsseldorf, , Germany

Site Status

Frankfurt, , Germany

Site Status

Freiburg im Breisgau, , Germany

Site Status

Halle, , Germany

Site Status

Hamburg, , Germany

Site Status

Kiel, , Germany

Site Status

Leipzig, , Germany

Site Status

München, , Germany

Site Status

Würzburg, , Germany

Site Status

Auckland, , New Zealand

Site Status

Christchurch, , New Zealand

Site Status

Hamilton, , New Zealand

Site Status

Bialystok, , Poland

Site Status

Bydgoszcz, , Poland

Site Status

Czeladź, , Poland

Site Status

Kielce, , Poland

Site Status

Krakow, , Poland

Site Status

Warsaw, , Poland

Site Status

Ponce Pr, , Puerto Rico

Site Status

San Juan, , Puerto Rico

Site Status

Moscow, , Russia

Site Status

Saint Petersburg, , Russia

Site Status

Samara, , Russia

Site Status

Smolensk, , Russia

Site Status

Stavropol, , Russia

Site Status

Barcelona, , Spain

Site Status

Madrid, , Spain

Site Status

Seville, , Spain

Site Status

Valencia, , Spain

Site Status

Birmingham, , United Kingdom

Site Status

Derby, , United Kingdom

Site Status

Glasgow, , United Kingdom

Site Status

London, , United Kingdom

Site Status

Plymouth, , United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Australia Austria Belgium Canada France Germany New Zealand Poland Puerto Rico Russia Spain United Kingdom

References

Explore related publications, articles, or registry entries linked to this study.

Lenz O, Verbinnen T, Fevery B, Tambuyzer L, Vijgen L, Peeters M, Buelens A, Ceulemans H, Beumont M, Picchio G, De Meyer S. Virology analyses of HCV isolates from genotype 1-infected patients treated with simeprevir plus peginterferon/ribavirin in Phase IIb/III studies. J Hepatol. 2015 May;62(5):1008-14. doi: 10.1016/j.jhep.2014.11.032. Epub 2014 Nov 28.

Reference Type DERIVED
PMID: 25445400 (View on PubMed)

Forns X, Lawitz E, Zeuzem S, Gane E, Bronowicki JP, Andreone P, Horban A, Brown A, Peeters M, Lenz O, Ouwerkerk-Mahadevan S, Scott J, De La Rosa G, Kalmeijer R, Sinha R, Beumont-Mauviel M. Simeprevir with peginterferon and ribavirin leads to high rates of SVR in patients with HCV genotype 1 who relapsed after previous therapy: a phase 3 trial. Gastroenterology. 2014 Jun;146(7):1669-79.e3. doi: 10.1053/j.gastro.2014.02.051. Epub 2014 Mar 3.

Reference Type DERIVED
PMID: 24602923 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

TMC435HPC3007

Identifier Type: OTHER

Identifier Source: secondary_id

2010-021113-23

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CR017371

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

A Study of TMC435350 Administered With or Without Standard of Care Therapy in Participants With Genotype 1 Hepatitis C Virus Infection
NCT00561353 COMPLETED PHASE2
A Study of TMC435 in Combination With Peginterferon Alfa-2A and Ribavirin for Hepatitis C Virus Genotype-1 Infected Patients Who Participated in a Control Group of a TMC435 Study
NCT01323244 COMPLETED PHASE3
A Safety and Effectiveness Study of TMC435 in Chronic, Genotype 1, Hepatitis C Patients Who Failed to Previous Standard Treatment
NCT00980330 COMPLETED PHASE2
TMC435HPC3001 - An Efficacy, Safety and Tolerability Study for TMC435 vs Telaprevir in Combination With PegINFα-2a and Ribavirin in Chronic Hepatitis C Patients Who Were Null or Partial Responders to Prior PegINFα-2a and Ribavirin Therapy
NCT01485991 COMPLETED PHASE3
A Study of TMC435 Plus Pegylated Interferon Alfa-2a and Ribavirin in Participants With Chronic HCV Infection
NCT01846832 COMPLETED PHASE3
A Study to Evaluate the Efficacy, Safety and Tolerability of TMC435 in Combination With PegIFN Alfa-2a (Pegasys) and Ribavirin (Copegus) in Treatment-Naïve or Treatment-Experienced, Chronic Hepatitis C Virus Genotype-4 Infected Patients
NCT01567735 COMPLETED PHASE3
A Phase III Study of TMC435 in Genotype 1, Hepatitis C-infected Participants Who Failed to Respond to Previous IFN-based Therapy
NCT01288209 COMPLETED PHASE3
A Study of TMC435 in Combination With Pegylated Interferon Alp\Fa-2a and Ribavirin in Patients Infected With Genotype 1 Hepatitis C Virus Who Never Received Treatment
NCT00882908 COMPLETED PHASE2
A Study of TMC435 in Participants With Genotype 1 Hepatitis C Virus (HCV) Infection
NCT01366638 COMPLETED PHASE3
A Study to Assess the Safety, Tolerability and Efficacy of TMC435 Along With Pegylated Interferon Alpha-2a (Pegasys) and Ribavirin (Copegus) Triple Therapy in Chronic Hepatitis C Genotype-1 Infected Patients Co-infected With Human Immunodeficiency Virus-Type 1
NCT01479868 COMPLETED PHASE3
A Study to Assess the Effectiveness, Safety, and Pharmacokinetics of TMC435 in Combination With Peginterferon Alfa-2a and Ribavirin in Hepatitis-C Infected Patients
NCT00996476 COMPLETED PHASE2
A Study of TMC435 in Combination With PSI-7977 (GS7977) in Chronic Hepatitis C Genotype 1-Infected Prior Null Responders To Peginterferon/Ribavirin Therapy or HCV Treatment-Naive Patients
NCT01466790 COMPLETED PHASE2
A Study to Evaluate the Safety, Tolerability, and Effectiveness of a 12-Week Combination Therapy of TMC647055 and TMC435 With and Without GSK23336805 With a Pharmacokinetic Enhancer With and Without Ribavirin in Patients Infected With Chronic Genotype 1 Hepatitis C Virus
NCT01724086 COMPLETED PHASE2
A Study to Assess the Anti-viral Activity, Safety, Tolerability and Pharmacokinetics of TMC435350 in Participants Infected With Hepatitis C-Virus (HCV)
NCT00812331 COMPLETED PHASE2
Efficacy, Safety and Tolerability of Ribavirin Monotherapy Followed by Combined Treatment With Ribavirin and Hydroxychloroquine in Patients Infected With Hepatitis C
NCT01833845 TERMINATED PHASE1/PHASE2
A Study to Evaluate the Efficacy and Safety of Three Experimental Drugs Compared With Telaprevir (a Licensed Product) in People With Hepatitis C Virus Infection Who Have Not Had Treatment Before
NCT01854697 COMPLETED PHASE3
Safety, Antiviral Activity and PK of MRD of BI 201335 in Chronic Hepatitis C Patients Both Treatment Naive and -Experienced
NCT00793793 COMPLETED PHASE1
3-year Follow-up Study in Patients Previously Treated With TMC435-Containing Regimen for the Treatment of Hepatitis C Virus Infection
NCT01349465 COMPLETED PHASE3
Efficacy Study of New Therapeutic Schedules in Naive Hepatitis C Virus (HCV) Patients Infected With Genotype 3 (HCV-3)
NCT01121705 COMPLETED PHASE3
A Phase III Study of BI201335 in Treatment-naive and Prior Relapser Patients With Chronic Hepatitis C Infection
NCT01608737 WITHDRAWN PHASE3
A Study of Drug-drug Interaction Between Ritonavir and TMC435350 in Healthy Volunteers
NCT01891851 COMPLETED PHASE1
TMC435350-TiDP16-C101 - A Study to Examine the Safety, Tolerability and Pharmacokinetics of Increasing Oral Doses of TMC435350 After Single and Repeated Dosing
NCT00938899 COMPLETED PHASE1
Safety, Tolerability, and Antiviral Activity of ACH-0141625 or Placebo in Combination With Peginterferon and Ribavirin in Hepatitis C Virus (HCV) Positive Participants
NCT01180790 COMPLETED PHASE2
Efficacy and Safety of MP-424, Peginterferon Alfa-2a (PEG-IFN Alfa-2a), and Ribavirin(RBV) in Treatment-Naïve or Relapsed Hepatitis C
NCT01753557 COMPLETED PHASE3
Safety and Efficacy Study of Pegylated Interferon Lambda Versus Pegylated Interferon Alfa, Plus Ribavirin in Subjects With Hepatitis C
NCT01447394 WITHDRAWN PHASE3