MedDataX Logo

Antiviral Effect, Safety, and Pharmacokinetics of BI201335 +PegIFN/RBV in HCV-GT1 (SILEN-C1&2)

NCT ID: NCT00774397

Last Updated: 2015-11-16

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

PHASE2

Total Enrollment

719 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Brief Summary

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

The objective was to investigate the antiviral effect, safety, and pharmacokinetics of BI 201335 (Faldaprevir), given as a soft gelatine capsule, in patients with hepatitis C virus (HCV) genotype 1 infection. Combination therapy of BI 201335 (Faldaprevir) with pegylated interferon α-2a (PegIFN) and ribavirin (RBV), with or without a 3-day lead-in, was assessed in treatment-naïve (TN) and treatment experienced (TE) patients.

Related Clinical Trials

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

Safety, Antiviral Activity and PK of MRD of BI 201335 in Chronic Hepatitis C Patients Both Treatment Naive and -Experienced

NCT00793793

Hepatitis C, Chronic
COMPLETED PHASE1

Short Term Treatment With BI 201335, Peginterferon-alpha 2a and Ribavirin in Hepatitis c Virus Genotype-1 Treatment-naïve Patients (SILEN-C3)

NCT00984620

Hepatitis C
COMPLETED PHASE2

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Oral Doses of BI 201335 as Softgel Capsule in Naive Hepatitis C Virus (HCV) Patients

NCT00947349

Hepatitis C Pharmacokinetics
COMPLETED PHASE2

Efficacy and Safety of BI 201335 (Faldaprevir) in Combination With Pegylated Interferon-alpha and Ribavirin in Treatment-naïve Genotype 1 Hepatitis C Infected Patients (STARTverso 2)

NCT01297270

Hepatitis C
COMPLETED PHASE3

IFN-free Combination Therapy in HCV-infected Patients Treatment-naive:HCVerso1

NCT01732796

Hepatitis C, Chronic
COMPLETED PHASE3

Detailed Description

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

Conditions

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

Hepatitis C, Chronic

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

DOUBLE

Study Groups

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

240 mg QD TN

240 mg BI 201335 NA (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients

Group Type EXPERIMENTAL

BI 201335 NA 240 mg QD

Intervention Type DRUG

240mg BI 201335 NA (Faldaprevir) once daily, 24 weeks

PegIFN/RBV

Intervention Type DRUG

PegIFN (180 µg/wk) and RBV (1000/1200mg/d),48 weeks

240 mg QD / LI-TN

240 mg BI 201335 NA (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 (Faldaprevir) three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients

Group Type EXPERIMENTAL

BI 201335 NA 240 mg QD / LI

Intervention Type DRUG

240mg BI 201335 NA (Faldaprevir) once daily with a 3 days lead-in phase of PegIFN/RB, 24 weeks

PegIFN/RBV

Intervention Type DRUG

PegIFN (180 µg/wk) and RBV (1000/1200mg/d), 24 or 48 weeks

Placebo

Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients

Group Type PLACEBO_COMPARATOR

PegIFN/RBV

Intervention Type DRUG

PegIFN (180 µg/wk) and RBV (1000/1200mg/d), 24 or 48 weeks

Placebo

Intervention Type DRUG

Placebo

120 mg QD / LI-TN

120 mg BI 201335 NA (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 (Faldaprevir) three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients

Group Type EXPERIMENTAL

BI 201335 NA 120mg QD / LI

Intervention Type DRUG

120mg BI 201335 NA (Faldaprevir) once daily, for 24 weeks

PegIFN/RBV

Intervention Type DRUG

PegIFN (180 µg/wk) and RBV (1000/1200mg/d),48 weeks

240 mg QD TE

240 mg BI 201335 NA (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients

Group Type EXPERIMENTAL

BI 201335 NA 240 mg QD

Intervention Type DRUG

240mg BI 201335 NA (Faldaprevir) once daily, 24 weeks

PegIFN/RBV

Intervention Type DRUG

PegIFN (180 µg/wk) and RBV (1000/1200mg/d), 24 or 48 weeks

240 mg QD / LI-TE

240 mg BI 201335 NA (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 (Faldaprevir) three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients

Group Type EXPERIMENTAL

PegIFN/RBV

Intervention Type DRUG

PegIFN (180 µg/wk) and RBV (1000/1200mg/d),48 weeks

BI 201335 NA 240 mg QD

Intervention Type DRUG

240mg BI 201335 NA (Faldaprevir) once daily, 24 weeks

240 mg BID / LI-TE

240mg BI 201335 NA (Faldaprevir) twice daily combined with PegIFN/RBV for 24 or 48 weeks, with 3-day lead-in phase of PegIFN/RBV, in treatment-experienced patients

Group Type EXPERIMENTAL

BI 201335 NA 240 mg BID

Intervention Type DRUG

240mg BI 201335 NA (Faldaprevir) twice, 24 weeks

PegIFN/RBV

Intervention Type DRUG

PegIFN (180 µg/wk) and RBV (1000/1200mg/d),48 weeks

Interventions

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

BI 201335 NA 240 mg QD / LI

240mg BI 201335 NA (Faldaprevir) once daily with a 3 days lead-in phase of PegIFN/RB, 24 weeks

Intervention Type DRUG

PegIFN/RBV

PegIFN (180 µg/wk) and RBV (1000/1200mg/d), 24 or 48 weeks

Intervention Type DRUG

BI 201335 NA 120mg QD / LI

120mg BI 201335 NA (Faldaprevir) once daily, for 24 weeks

Intervention Type DRUG

PegIFN/RBV

PegIFN (180 µg/wk) and RBV (1000/1200mg/d),48 weeks

Intervention Type DRUG

BI 201335 NA 240 mg QD

240mg BI 201335 NA (Faldaprevir) once daily, 24 weeks

Intervention Type DRUG

PegIFN/RBV

PegIFN (180 µg/wk) and RBV (1000/1200mg/d),48 weeks

Intervention Type DRUG

BI 201335 NA 240 mg QD

240mg BI 201335 NA (Faldaprevir) once daily, 24 weeks

Intervention Type DRUG

PegIFN/RBV

PegIFN (180 µg/wk) and RBV (1000/1200mg/d), 24 or 48 weeks

Intervention Type DRUG

BI 201335 NA 240 mg BID

240mg BI 201335 NA (Faldaprevir) twice, 24 weeks

Intervention Type DRUG

PegIFN/RBV

PegIFN (180 µg/wk) and RBV (1000/1200mg/d),48 weeks

Intervention Type DRUG

PegIFN/RBV

PegIFN (180 µg/wk) and RBV (1000/1200mg/d),48 weeks

Intervention Type DRUG

BI 201335 NA 240 mg QD

240mg BI 201335 NA (Faldaprevir) once daily, 24 weeks

Intervention Type DRUG

PegIFN/RBV

PegIFN (180 µg/wk) and RBV (1000/1200mg/d), 24 or 48 weeks

Intervention Type DRUG

Placebo

Placebo

Intervention Type DRUG

Other Intervention Names

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

Faldaprevir Faldaprevir Faldaprevir Faldaprevir Faldaprevir Faldaprevir

Eligibility Criteria

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

Inclusion Criteria

chronic HCV GT1; therapy-naive to IFN, PegIFN, or RBV; HCV VL \>=100,000 IU/mL Liver biopsy within 2 years prior to study enrolment showing necroinflammatory activity or presence of fibrosis Normal retinal finding on fundoscopy within 6 months prior to Day 1 age 18-65 years Females and males with adequate contraception
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

Boehringer Ingelheim

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.

Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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

1220.5.0001 Boehringer Ingelheim Investigational Site

San Francisco, California, United States

Site Status

1220.5.0008 Boehringer Ingelheim Investigational Site

San Francisco, California, United States

Site Status

1220.5.0005 Boehringer Ingelheim Investigational Site

Chicago, Illinois, United States

Site Status

1220.5.0006 Boehringer Ingelheim Investigational Site

Lutherville, Maryland, United States

Site Status

1220.5.0002 Boehringer Ingelheim Investigational Site

New York, New York, United States

Site Status

1220.5.0003 Boehringer Ingelheim Investigational Site

New York, New York, United States

Site Status

1220.5.0007 Boehringer Ingelheim Investigational Site

Philadelphia, Pennsylvania, United States

Site Status

1220.5.0010 Boehringer Ingelheim Investigational Site

Germantown, Tennessee, United States

Site Status

1220.5.0009 Boehringer Ingelheim Investigational Site

Nashville, Tennessee, United States

Site Status

1220.5.0004 Boehringer Ingelheim Investigational Site

Austin, Texas, United States

Site Status

1220.5.5401 Boehringer Ingelheim Investigational Site

Capital Federal, , Argentina

Site Status

1220.5.5403 Boehringer Ingelheim Investigational Site

Capital Federal, , Argentina

Site Status

1220.5.5405 Boehringer Ingelheim Investigational Site

Derqui, Pilar, , Argentina

Site Status

1220.5.5402 Boehringer Ingelheim Investigational Site

Rosario, , Argentina

Site Status

1220.5.5406 Boehringer Ingelheim Investigational Site

Rosario, , Argentina

Site Status

1220.5.6110 Boehringer Ingelheim Investigational Site

Camperdown, New South Wales, Australia

Site Status

1220.5.6109 Boehringer Ingelheim Investigational Site

Kogarah, New South Wales, Australia

Site Status

1220.5.6105 Boehringer Ingelheim Investigational Site

Randwick, New South Wales, Australia

Site Status

1220.5.6101 Boehringer Ingelheim Investigational Site

Westmead, New South Wales, Australia

Site Status

1220.5.6103 Boehringer Ingelheim Investigational Site

Herston, Queensland, Australia

Site Status

1220.5.6104 Boehringer Ingelheim Investigational Site

Woolloongabba, Queensland, Australia

Site Status

1220.5.6102 Boehringer Ingelheim Investigational Site

Clayton, Victoria, Australia

Site Status

1220.5.6107 Boehringer Ingelheim Investigational Site

Fitzroy, Victoria, Australia

Site Status

1220.5.6108 Boehringer Ingelheim Investigational Site

Parkville, Victoria, Australia

Site Status

1220.5.4303 Boehringer Ingelheim Investigational Site

Linz, , Austria

Site Status

1220.5.4301 Boehringer Ingelheim Investigational Site

Vienna, , Austria

Site Status

1220.5.4302 Boehringer Ingelheim Investigational Site

Vienna, , Austria

Site Status

1220.5.1003 Boehringer Ingelheim Investigational Site

Edmonton, Alberta, Canada

Site Status

1220.5.1007 Boehringer Ingelheim Investigational Site

Vancouver, British Columbia, Canada

Site Status

1220.5.1006 Boehringer Ingelheim Investigational Site

Hamilton, Ontario, Canada

Site Status

1220.5.1001 Boehringer Ingelheim Investigational Site

Ottawa, Ontario, Canada

Site Status

1220.5.1002 Boehringer Ingelheim Investigational Site

Toronto, Ontario, Canada

Site Status

1220.5.1004 Boehringer Ingelheim Investigational Site

Montreal, Quebec, Canada

Site Status

1220.5.4202 Boehringer Ingelheim Investigational Site

Mělník, , Czechia

Site Status

1220.5.4203 Boehringer Ingelheim Investigational Site

Opava, , Czechia

Site Status

1220.5.3301A Boehringer Ingelheim Investigational Site

Clichy, , France

Site Status

1220.5.3307A Boehringer Ingelheim Investigational Site

Créteil, , France

Site Status

1220.5.3309A Boehringer Ingelheim Investigational Site

Lyon, , France

Site Status

1220.5.3304A Boehringer Ingelheim Investigational Site

Marseille, , France

Site Status

1220.5.3306A Boehringer Ingelheim Investigational Site

Montpellier, , France

Site Status

1220.5.3302A Boehringer Ingelheim Investigational Site

Paris, , France

Site Status

1220.5.3303A Boehringer Ingelheim Investigational Site

Paris, , France

Site Status

1220.5.3308A Boehringer Ingelheim Investigational Site

Paris, , France

Site Status

1220.5.3305A Boehringer Ingelheim Investigational Site

Vandœuvre-lès-Nancy, , France

Site Status

1220.5.4902 Boehringer Ingelheim Investigational Site

Berlin, , Germany

Site Status

1220.5.4903 Boehringer Ingelheim Investigational Site

Berlin, , Germany

Site Status

1220.5.4917 Boehringer Ingelheim Investigational Site

Berlin, , Germany

Site Status

1220.5.4914 Boehringer Ingelheim Investigational Site

Bochum, , Germany

Site Status

1220.5.4913 Boehringer Ingelheim Investigational Site

Bonn, , Germany

Site Status

1220.5.4915 Boehringer Ingelheim Investigational Site

Dortmund, , Germany

Site Status

1220.5.4905 Boehringer Ingelheim Investigational Site

Düsseldorf, , Germany

Site Status

1220.5.4912 Boehringer Ingelheim Investigational Site

Düsseldorf, , Germany

Site Status

1220.5.4906 Boehringer Ingelheim Investigational Site

Frankfurt am Main, , Germany

Site Status

1220.5.4908 Boehringer Ingelheim Investigational Site

Hamburg, , Germany

Site Status

1220.5.4904 Boehringer Ingelheim Investigational Site

Hanover, , Germany

Site Status

1220.5.4910 Boehringer Ingelheim Investigational Site

Leipzig, , Germany

Site Status

1220.5.4909 Boehringer Ingelheim Investigational Site

Mainz, , Germany

Site Status

1220.5.4907 Boehringer Ingelheim Investigational Site

Tübingen, , Germany

Site Status

1220.5.3101 Boehringer Ingelheim Investigational Site

Amsterdam, , Netherlands

Site Status

1220.5.3102 Boehringer Ingelheim Investigational Site

Leiden, , Netherlands

Site Status

1220.5.3501 Boehringer Ingelheim Investigational Site

Coimbra, , Portugal

Site Status

1220.5.3504 Boehringer Ingelheim Investigational Site

Coimbra, , Portugal

Site Status

1220.5.3502 Boehringer Ingelheim Investigational Site

Lisbon, , Portugal

Site Status

1220.5.3503 Boehringer Ingelheim Investigational Site

Lisbon, , Portugal

Site Status

1220.5.3506 Boehringer Ingelheim Investigational Site

Porto, , Portugal

Site Status

1220.5.3507 Boehringer Ingelheim Investigational Site

Porto, , Portugal

Site Status

1220.5.4001 Boehringer Ingelheim Investigational Site

Bucharest, , Romania

Site Status

1220.5.4002 Boehringer Ingelheim Investigational Site

Bucharest, , Romania

Site Status

1220.5.4003 Boehringer Ingelheim Investigational Site

Bucharest, , Romania

Site Status

1220.5.4004 Boehringer Ingelheim Investigational Site

Bucharest, , Romania

Site Status

1220.5.8210 Boehringer Ingelheim Investigational Site

Busan, , South Korea

Site Status

1220.5.8205 Boehringer Ingelheim Investigational Site

Daegu, , South Korea

Site Status

1220.5.8201 Boehringer Ingelheim Investigational Site

Pusan, , South Korea

Site Status

1220.5.8202 Boehringer Ingelheim Investigational Site

Seoul, , South Korea

Site Status

1220.5.8206 Boehringer Ingelheim Investigational Site

Seoul, , South Korea

Site Status

1220.5.8207 Boehringer Ingelheim Investigational Site

Seoul, , South Korea

Site Status

1220.5.8208 Boehringer Ingelheim Investigational Site

Seoul, , South Korea

Site Status

1220.5.8204 Boehringer Ingelheim Investigational Site

Seoungnam, , South Korea

Site Status

1220.5.8203 Boehringer Ingelheim Investigational Site

Sungnam, , South Korea

Site Status

1220.5.8209 Boehringer Ingelheim Investigational Site

Suwon, , South Korea

Site Status

1220.5.8211 Boehringer Ingelheim Investigational Site

Yangsan, , South Korea

Site Status

1220.5.3402 Boehringer Ingelheim Investigational Site

Barcelona, , Spain

Site Status

1220.5.3405 Boehringer Ingelheim Investigational Site

Barcelona, , Spain

Site Status

1220.5.3401 Boehringer Ingelheim Investigational Site

Madrid, , Spain

Site Status

1220.5.3403 Boehringer Ingelheim Investigational Site

Madrid, , Spain

Site Status

1220.5.3404 Boehringer Ingelheim Investigational Site

Madrid, , Spain

Site Status

1220.5.3406 Boehringer Ingelheim Investigational Site

Madrid, , Spain

Site Status

1220.5.4104 Boehringer Ingelheim Investigational Site

Bern, , Switzerland

Site Status

1220.5.4102 Boehringer Ingelheim Investigational Site

La Chaux-de-Fonds, , Switzerland

Site Status

1220.5.4103 Boehringer Ingelheim Investigational Site

Lugano, , Switzerland

Site Status

1220.5.4101 Boehringer Ingelheim Investigational Site

Zurich, , Switzerland

Site Status

1220.5.4106 Boehringer Ingelheim Investigational Site

Zurich, , Switzerland

Site Status

1220.5.4405 Boehringer Ingelheim Investigational Site

Bristol, , United Kingdom

Site Status

1220.5.4401 Boehringer Ingelheim Investigational Site

London, , United Kingdom

Site Status

1220.5.4402 Boehringer Ingelheim Investigational Site

London, , United Kingdom

Site Status

1220.5.4406 Boehringer Ingelheim Investigational Site

London, , United Kingdom

Site Status

1220.5.4409 Boehringer Ingelheim Investigational Site

London, , United Kingdom

Site Status

1220.5.4410 Boehringer Ingelheim Investigational Site

London, , United Kingdom

Site Status

1220.5.4408 Boehringer Ingelheim Investigational Site

Nottingham, , United Kingdom

Site Status

1220.5.4403 Boehringer Ingelheim Investigational Site

Southampton, , United Kingdom

Site Status

Countries

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

United States Argentina Australia Austria Canada Czechia France Germany Netherlands Portugal Romania South Korea Spain Switzerland United Kingdom

Other Identifiers

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

2008-003538-11

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1220.5

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

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

Efficacy and Safety of BI 201335 (Faldaprevir) in Combination With Pegylated Interferon-alpha and Ribavirin in Treatment-naïve Genotype 1 Hepatitis C Infected Patients (STARTverso 1)
NCT01343888 COMPLETED PHASE3
A Phase III Study of BI201335 in Treatment-naive and Prior Relapser Patients With Chronic Hepatitis C Infection
NCT01608737 WITHDRAWN PHASE3
Safety, Antiviral Effect and PK of BI 207127 + BI 201335 +/- RBV for 4 up to 40 Weeks in Patients With Chronic HCV Genotype 1 Infection
NCT01132313 COMPLETED PHASE2
Study of PPI-668, BI 207127 and Faldaprevir, With and Without Ribavirin, in the Treatment of Chronic Hepatitis C
NCT01859962 COMPLETED PHASE2
Multiple Oral Doses of BI 207127 NA in Treatment naïve and Treatment-experienced Hepatitis C Virus (HCV)-Infected Patients
NCT02176525 COMPLETED PHASE1
Efficacy and Safety of BI 201335 (Faldaprevir) in Combination With Pegylated Interferon-alpha and Ribavirin in Treatment-Experienced Genotype 1 Hepatitis C Infected Patients (STARTverso 3)
NCT01358864 COMPLETED PHASE3
Phase 3 Study of BI 207127 in Combination With Faldaprevir and Ribavirin for Treatment of Patients With Hepatitis C Infection, Including Patients Who Are Not Eligible to Receive Peginterferon: HCVerso2
NCT01728324 COMPLETED PHASE3
Open Label Trial to Compare BI 207127 to Telaprevir in HCV Patients
NCT01858961 WITHDRAWN PHASE3
BI 207127 / Faldaprevir Combination Therapy in Hepatic Impairment (Child-Pugh B) Patients With Genotype 1b Chronic Hepatitis C Infection: HCVerso3
NCT01830127 COMPLETED PHASE2
An Efficacy, Pharmacokinetics, Safety and Tolerability Study of TMC435 as Part of a Treatment Regimen for Hepatitis C-Infected Patients
NCT01725529 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
A Study to Evaluate the Safety, Antiviral Effect, and Pharmacokinetics of Celgosivir in Combination With Peginterferon Alfa-2b and Ribavirin in Treatment-Naïve Patients With Chronic Hepatitis C
NCT00332176 UNKNOWN PHASE2
Filibuvir In Treatment Naive Hepatitis C Virus (HCV) Genotype 1 Subjects
NCT00987337 COMPLETED PHASE2
Phase III Trial of BI 201335 (Faldaprevir) in Treatment Naive (TN) and Relapser Hepatitis C Virus (HCV)-Human Immunodeficiency Virus (HIV) Coinfected Patients (STARTverso 4)
NCT01399619 COMPLETED PHASE3
CPG10101 Combination Therapy For The Treatment Of Hepatitis C In Non-Responder (Null And Partial Responder) Hepatitis C Virus (HCV) Genotype 1 Infected Subjects
NCT00277238 COMPLETED PHASE2
An Efficacy, Safety, and Tolerability Study of TMC435 in Treatment-naive, Genotype 1 Hepatitis C-infected Patients
NCT01289782 COMPLETED PHASE3
Study of Nitazoxanide, Peginterferon Alfa-2a and Ribavirin in Treatment-Naive Hepatitis C Patients
NCT00637923 COMPLETED PHASE2
A Rollover Study of BI 201335 in Combination With Pegylated Interferon-alpha and Ribavirin in Treatment-experienced Genotype 1 Hepatitis C Infected Patients
NCT01330316 COMPLETED PHASE3
Valopicitabine When Administered Alone and in Combination With Interferon to Treatment-Naive Patients With Hepatitis C
NCT00120835 COMPLETED PHASE1/PHASE2
To Evaluate Efficacy and Safety in TG-2349 Combination With DAG181 (± Ribavirin) in HCV Genotype I Infected Patients
NCT03593447 COMPLETED PHASE2
A Study to Evaluate the Combination of Pegylated Interferon Alfa Plus Valopicitabine in Patients With Hepatitis C
NCT00118768 COMPLETED PHASE2
A Study of Faldaprevir, TD-6450 and Other Antivirals in Participants With Genotype 1b Hepatitis C Virus Infection
NCT02716428 COMPLETED PHASE2
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 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
An Observational Study of Peginterferon (e.g. Pegasys)-Based Direct Acting Antiviral Triple Therapy in Patients With Chronic Hepatitis C Genotype 1
NCT01508130 COMPLETED