MedDataX Logo

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)

NCT ID: NCT01358864

Last Updated: 2016-08-29

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

678 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2014-05-31

Brief Summary

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

The aim of this trial is to evaluate the efficacy and the safety of BI 201335 given for 12 or 24 weeks in combination with PegIFN/RBV given for 48 weeks as compared to PegIFN/RBV alone in chronic GT-1 hepatitis C virus infected patients who failed a prior PegIFN/RBV treatment.

Related Clinical Trials

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

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

Hepatitis C
COMPLETED PHASE3

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

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

Hepatitis C, Chronic
COMPLETED PHASE3

A Rollover Study of BI 201335 in Combination With Pegylated Interferon-alpha and Ribavirin in Treatment-experienced Genotype 1 Hepatitis C Infected Patients

NCT01330316

Hepatitis C
COMPLETED PHASE3

A Phase III Study of BI201335 in Treatment-naive and Prior Relapser Patients With Chronic Hepatitis C Infection

NCT01608737

Hepatitis C, Chronic
WITHDRAWN PHASE3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

Participants Investigators

Study Groups

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

Placebo/PegIFN/RBV

patient to receive two capsules identical to those containing BI201335 once a day for 24 weeks and PegIFN/RBV for 48 weeks

Group Type ACTIVE_COMPARATOR

Pegylated Interferon-alpha (IFN)

Intervention Type DRUG

Pegylated Interferon-alpha for 48 weeks

Ribavirin (RBV)

Intervention Type DRUG

Ribavirin (RBV) for 24 or 48 weeks

Placebo

Intervention Type DRUG

Placebo to BI201335 for 24 weeks

BI201335 12 weeks

patient to receive two capsules containing BI 201335 once a day for 12 weeks and PegIFN/RBV for 48 weeks

Group Type EXPERIMENTAL

BI 201335

Intervention Type DRUG

BI 201335 once a day (QD) for 24 weeks

Pegylated Interferon-alpha (IFN)

Intervention Type DRUG

Pegylated Interferon-alpha for 48 weeks

Ribavirin (RBV)

Intervention Type DRUG

Ribavirin (RBV) for 24 or 48 weeks

BI201335 24 weeks

patient to receive two capsules containing BI 201335 once a day for 24 weeks and PegIFN/RBV for 48 weeks

Group Type EXPERIMENTAL

BI 201335

Intervention Type DRUG

BI 201335 once a day (QD) for 24 weeks

Pegylated Interferon-alpha (IFN)

Intervention Type DRUG

Pegylated Interferon-alpha for 48 weeks

Ribavirin (RBV)

Intervention Type DRUG

Ribavirin (RBV) for 24 or 48 weeks

Interventions

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

BI 201335

BI 201335 once a day (QD) for 24 weeks

Intervention Type DRUG

Pegylated Interferon-alpha (IFN)

Pegylated Interferon-alpha for 48 weeks

Intervention Type DRUG

Ribavirin (RBV)

Ribavirin (RBV) for 24 or 48 weeks

Intervention Type DRUG

Placebo

Placebo to BI201335 for 24 weeks

Intervention Type DRUG

Eligibility Criteria

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

Inclusion Criteria

1. Chronic hepatitis C genotype 1 infection, diagnosed at least 6 months prior to screening
2. Confirmed prior virological failure with an approved dose of PegIFN/RBV
3. Age 18 to 70 years,
4. HCV RNA (RiboNucleic Acid) = 1,000 IU/mL at screening,

Exclusion Criteria

1. HCV infection of mixed genotype; Hepatitis B Virus (HBV) or Human Immunodeficiency Virus (HIV) co-infection
2. Evidence of acute or chronic liver disease due to causes other than chronic HCV infection,
3. Decompensated liver disease, or history of decompensated liver disease,
4. Body weight \< 40 or \> 125 kg,
5. Clinical evidence of significant or unstable cardiovascular disease, chronic pulmonary disease, history or evidence of retinopathy or clinically significant ophthalmological disorder
6. Pre-existing psychiatric condition that could interfere with the subject's participation in and completion of the study
7. Laboratory parameters disorders (thalassemia major, sickle cell anemia or G6PD deficit)
8. Hemoglobin \< 12 g/dL for women and \< 13 g/dL for men
9. Patients who have been previously treated with at least one dose of any antiviral or immunomodulatory drug other than interferon alfa or ribavirin for acute or chronic HCV infection including and not restricted to protease or polymerase inhibitors,
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 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.

1220.7.0091 Boehringer Ingelheim Investigational Site

North Little Rock, Arkansas, United States

Site Status

1220.7.0082 Boehringer Ingelheim Investigational Site

Englewood, Colorado, United States

Site Status

1220.7.0095 Boehringer Ingelheim Investigational Site

Palm Harbor, Florida, United States

Site Status

1220.7.0039 Boehringer Ingelheim Investigational Site

Columbus, Georgia, United States

Site Status

1220.7.0013 Boehringer Ingelheim Investigational Site

Chicago, Illinois, United States

Site Status

1220.7.0062 Boehringer Ingelheim Investigational Site

Vaiparaiso, Indiana, United States

Site Status

1220.7.0085 Boehringer Ingelheim Investigational Site

Baton Rouge, Louisiana, United States

Site Status

1220.7.0087 Boehringer Ingelheim Investigational Site

Baton Rouge, Louisiana, United States

Site Status

1220.7.0101 Boehringer Ingelheim Investigational Site

New Orleans, Louisiana, United States

Site Status

1220.7.0027 Boehringer Ingelheim Investigational Site

Framingham, Massachusetts, United States

Site Status

1220.7.0012 Boehringer Ingelheim Investigational Site

New York, New York, United States

Site Status

1220.7.0077 Boehringer Ingelheim Investigational Site

Winston-Salem, North Carolina, United States

Site Status

1220.7.0058 Boehringer Ingelheim Investigational Site

Portland, Oregon, United States

Site Status

1220.7.0063 Boehringer Ingelheim Investigational Site

Arlington, Texas, United States

Site Status

1220.7.0029 Boehringer Ingelheim Investigational Site

Austin, Texas, United States

Site Status

1220.7.0071 Boehringer Ingelheim Investigational Site

Dallas, Texas, United States

Site Status

1220.7.0009 Boehringer Ingelheim Investigational Site

Houston, Texas, United States

Site Status

1220.7.0016 Boehringer Ingelheim Investigational Site

San Antonio, Texas, United States

Site Status

1220.7.4303 Boehringer Ingelheim Investigational Site

Linz, , Austria

Site Status

1220.7.4301 Boehringer Ingelheim Investigational Site

Vienna, , Austria

Site Status

1220.7.4302 Boehringer Ingelheim Investigational Site

Vienna, , Austria

Site Status

1220.7.3201 Boehringer Ingelheim Investigational Site

Brussels, , Belgium

Site Status

1220.7.3207 Boehringer Ingelheim Investigational Site

Brussels, , Belgium

Site Status

1220.7.3204 Boehringer Ingelheim Investigational Site

Edegem, , Belgium

Site Status

1220.7.3205 Boehringer Ingelheim Investigational Site

Ghent, , Belgium

Site Status

1220.7.3206 Boehringer Ingelheim Investigational Site

Jette, , Belgium

Site Status

1220.7.3202 Boehringer Ingelheim Investigational Site

Leuven, , Belgium

Site Status

1220.7.3203 Boehringer Ingelheim Investigational Site

Liège, , Belgium

Site Status

1220.7.1011 Boehringer Ingelheim Investigational Site

Calgary, Alberta, Canada

Site Status

1220.7.1012 Boehringer Ingelheim Investigational Site

Edmonton, Alberta, Canada

Site Status

1220.7.1003 Boehringer Ingelheim Investigational Site

Vancouver, British Columbia, Canada

Site Status

1220.7.1016 Boehringer Ingelheim Investigational Site

Vancouver, British Columbia, Canada

Site Status

1220.7.1007 Boehringer Ingelheim Investigational Site

Victoria, British Columbia, Canada

Site Status

1220.7.1004 Boehringer Ingelheim Investigational Site

Ottawa, Ontario, Canada

Site Status

1220.7.1006 Boehringer Ingelheim Investigational Site

Toronto, Ontario, Canada

Site Status

1220.7.1010 Boehringer Ingelheim Investigational Site

Montreal, Quebec, Canada

Site Status

1220.7.1014 Boehringer Ingelheim Investigational Site

Montreal, Quebec, Canada

Site Status

1220.7.3301 Boehringer Ingelheim Investigational Site

Clichy, , France

Site Status

1220.7.3311 Boehringer Ingelheim Investigational Site

Lille, , France

Site Status

1220.7.3303 Boehringer Ingelheim Investigational Site

Marseille, , France

Site Status

1220.7.3304 Boehringer Ingelheim Investigational Site

Montpellier, , France

Site Status

1220.7.3305 Boehringer Ingelheim Investigational Site

Nice, , France

Site Status

1220.7.3302 Boehringer Ingelheim Investigational Site

Paris, , France

Site Status

1220.7.3310 Boehringer Ingelheim Investigational Site

Paris, , France

Site Status

1220.7.3316 Boehringer Ingelheim Investigational Site

Pessac, , France

Site Status

1220.7.3317 Boehringer Ingelheim Investigational Site

Reims, , France

Site Status

1220.7.3315 Boehringer Ingelheim Investigational Site

Rennes, , France

Site Status

1220.7.3318 Boehringer Ingelheim Investigational Site

Strasbourg, , France

Site Status

1220.7.3308 Boehringer Ingelheim Investigational Site

Vandœuvre-lès-Nancy, , France

Site Status

1220.7.4902 Boehringer Ingelheim Investigational Site

Berlin, , Germany

Site Status

1220.7.4904 Boehringer Ingelheim Investigational Site

Berlin, , Germany

Site Status

1220.7.4913 Boehringer Ingelheim Investigational Site

Dortmund, , Germany

Site Status

1220.7.4906 Boehringer Ingelheim Investigational Site

Düsseldorf, , Germany

Site Status

1220.7.4901 Boehringer Ingelheim Investigational Site

Frankfurt am Main, , Germany

Site Status

1220.7.4908 Boehringer Ingelheim Investigational Site

Hamburg, , Germany

Site Status

1220.7.4918 Boehringer Ingelheim Investigational Site

Hanover, , Germany

Site Status

1220.7.4907 Boehringer Ingelheim Investigational Site

Herne, , Germany

Site Status

1220.7.4903 Boehringer Ingelheim Investigational Site

Leipzig, , Germany

Site Status

1220.7.4911 Boehringer Ingelheim Investigational Site

Mainz, , Germany

Site Status

1220.7.4905 Boehringer Ingelheim Investigational Site

München, , Germany

Site Status

1220.7.8106 Boehringer Ingelheim Investigational Site

Chiba, Chiba, , Japan

Site Status

1220.7.8111 Boehringer Ingelheim Investigational Site

Gifu, Gifu, , Japan

Site Status

1220.7.8107 Boehringer Ingelheim Investigational Site

Itabashi-ku, Tokyo, , Japan

Site Status

1220.7.8112 Boehringer Ingelheim Investigational Site

Izunokuni, Shizuoka, , Japan

Site Status

1220.7.8108 Boehringer Ingelheim Investigational Site

Kamakura, Kanagawa, , Japan

Site Status

1220.7.8117 Boehringer Ingelheim Investigational Site

Kita-gun, Kagawa, , Japan

Site Status

1220.7.8109 Boehringer Ingelheim Investigational Site

Kofu, Yamanashi, , Japan

Site Status

1220.7.8116 Boehringer Ingelheim Investigational Site

Kurashiki, Okayama, , Japan

Site Status

1220.7.8118 Boehringer Ingelheim Investigational Site

Kurume, Fukuoka, , Japan

Site Status

1220.7.8110 Boehringer Ingelheim Investigational Site

Matsumoto, Nagano, , Japan

Site Status

1220.7.8124 Boehringer Ingelheim Investigational Site

Matsuyama, Ehime, , Japan

Site Status

1220.7.8113 Boehringer Ingelheim Investigational Site

Nagoya, Aichi, , Japan

Site Status

1220.7.8105 Boehringer Ingelheim Investigational Site

Namegata, Ibaraki, , Japan

Site Status

1220.7.8114 Boehringer Ingelheim Investigational Site

Nishinomiya, Hyogo, , Japan

Site Status

1220.7.8125 Boehringer Ingelheim Investigational Site

Ogaki, Gifu, , Japan

Site Status

1220.7.8119 Boehringer Ingelheim Investigational Site

Omura, Nagasaki, , Japan

Site Status

1220.7.8122 Boehringer Ingelheim Investigational Site

Omuta, Fukuoka, , Japan

Site Status

1220.7.8121 Boehringer Ingelheim Investigational Site

Osaka, Osaka, , Japan

Site Status

1220.7.8101 Boehringer Ingelheim Investigational Site

Sapporo, Hokkaido, , Japan

Site Status

1220.7.8102 Boehringer Ingelheim Investigational Site

Sendai, Miyagi, , Japan

Site Status

1220.7.8115 Boehringer Ingelheim Investigational Site

Tanabe, Wakayama, , Japan

Site Status

1220.7.8123 Boehringer Ingelheim Investigational Site

Toyama,Toyama, , Japan

Site Status

1220.7.8126 Boehringer Ingelheim Investigational Site

Tsu, Mie, , Japan

Site Status

1220.7.8104 Boehringer Ingelheim Investigational Site

Tsuchiura, Ibaraki, , Japan

Site Status

1220.7.3503 Boehringer Ingelheim Investigational Site

Aveiro, , Portugal

Site Status

1220.7.3509 Boehringer Ingelheim Investigational Site

Barreiro, , Portugal

Site Status

1220.7.3506 Boehringer Ingelheim Investigational Site

Coimbra, , Portugal

Site Status

1220.7.3501 Boehringer Ingelheim Investigational Site

Lisbon, , Portugal

Site Status

1220.7.3505 Boehringer Ingelheim Investigational Site

Lisbon, , Portugal

Site Status

1220.7.3502 Boehringer Ingelheim Investigational Site

Porto, , Portugal

Site Status

1220.7.0034 Boehringer Ingelheim Investigational Site

San Juan, , Puerto Rico

Site Status

1220.7.3406 Boehringer Ingelheim Investigational Site

A Coruña, , Spain

Site Status

1220.7.3402 Boehringer Ingelheim Investigational Site

Barcelona, , Spain

Site Status

1220.7.3404 Boehringer Ingelheim Investigational Site

Barcelona, , Spain

Site Status

1220.7.3411 Boehringer Ingelheim Investigational Site

Barcelona, , Spain

Site Status

1220.7.3412 Boehringer Ingelheim Investigational Site

Barcelona, , Spain

Site Status

1220.7.3405 Boehringer Ingelheim Investigational Site

Madrid, , Spain

Site Status

1220.7.3409 Boehringer Ingelheim Investigational Site

Madrid, , Spain

Site Status

1220.7.3410 Boehringer Ingelheim Investigational Site

Majadahonda-Madrid, , Spain

Site Status

1220.7.3408 Boehringer Ingelheim Investigational Site

Santander, , Spain

Site Status

1220.7.3403 Boehringer Ingelheim Investigational Site

Seville, , Spain

Site Status

1220.7.3401 Boehringer Ingelheim Investigational Site

Valencia, , Spain

Site Status

1220.7.3407 Boehringer Ingelheim Investigational Site

Vigo (Pontevedra), , Spain

Site Status

1220.7.4106 Boehringer Ingelheim Investigational Site

Bern, , Switzerland

Site Status

1220.7.4103 Boehringer Ingelheim Investigational Site

La Chaux-de-Fonds, , Switzerland

Site Status

1220.7.4107 Boehringer Ingelheim Investigational Site

Lugano, , Switzerland

Site Status

1220.7.4108 Boehringer Ingelheim Investigational Site

Sankt Gallen, , Switzerland

Site Status

1220.7.4101 Boehringer Ingelheim Investigational Site

Zurich, , Switzerland

Site Status

1220.7.4405 Boehringer Ingelheim Investigational Site

Bristol, , United Kingdom

Site Status

1220.7.4404 Boehringer Ingelheim Investigational Site

London, , United Kingdom

Site Status

1220.7.4409 Boehringer Ingelheim Investigational Site

London, , United Kingdom

Site Status

1220.7.4410 Boehringer Ingelheim Investigational Site

London, , United Kingdom

Site Status

1220.7.4401 Boehringer Ingelheim Investigational Site

Manchester, , United Kingdom

Site Status

1220.7.4408 Boehringer Ingelheim Investigational Site

Nottingham, , United Kingdom

Site Status

1220.7.4407 Boehringer Ingelheim Investigational Site

Oxford, , United Kingdom

Site Status

1220.7.4403 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 Austria Belgium Canada France Germany Japan Portugal Puerto Rico Spain Switzerland United Kingdom

Other Identifiers

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

2010-021715-17

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1220.7

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

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

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
Safety, Antiviral Activity and PK of MRD of BI 201335 in Chronic Hepatitis C Patients Both Treatment Naive and -Experienced
NCT00793793 COMPLETED PHASE1
Open Label Trial to Compare BI 207127 to Telaprevir in HCV Patients
NCT01858961 WITHDRAWN PHASE3
Antiviral Effect, Safety, and Pharmacokinetics of BI201335 +PegIFN/RBV in HCV-GT1 (SILEN-C1&2)
NCT00774397 COMPLETED PHASE2
Study of PPI-668, BI 207127 and Faldaprevir, With and Without Ribavirin, in the Treatment of Chronic Hepatitis C
NCT01859962 COMPLETED PHASE2
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
IFN-free Combination Therapy in HCV-infected Patients Treatment-naive:HCVerso1
NCT01732796 COMPLETED PHASE3
BI 207127 / Faldaprevir Combination Therapy in Hepatic Impairment (Child-Pugh B) Patients With Genotype 1b Chronic Hepatitis C Infection: HCVerso3
NCT01830127 COMPLETED PHASE2
Japanese Pegylated Interferon (PegIFN) Alfa-2b/Ribavirin (RBV) Combination Trial
NCT01579474 COMPLETED PHASE3
Short Term Treatment With BI 201335, Peginterferon-alpha 2a and Ribavirin in Hepatitis c Virus Genotype-1 Treatment-naïve Patients (SILEN-C3)
NCT00984620 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 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
Pilot Trial of Bavituximab Combined With Ribavirin for Initial Treatment of Chronic HepC Virus Genotype 1 Infection
NCT01273948 COMPLETED PHASE1/PHASE2
A Study of Debio 025 (Alisporivir) Combined With Peg-IFNα2a and Ribavirin in Treatment naïve Chronic Hepatitis C Genotype 1 Patients
NCT00854802 COMPLETED NA
Safety and Antiviral Activity of IDX184 in Combination With Pegylated Interferon and Ribavirin for 12 Weeks (MK-2355-005)
NCT01371604 COMPLETED PHASE2
Study to Evaluate Drug-drug Interaction Between Valopicitabine and Ribavirin
NCT00395421 COMPLETED PHASE2
A Study of Setrobuvir in Combination With Pegasys (Peginterferon Alfa-2a) and Copegus (Ribavirin) in Patients With Genotype 1 Chronic Hepatitis C
NCT01903954 COMPLETED PHASE2
Safety and Efficacy of Boceprevir in Asia Pacific Participants With Chronic Hepatitis C Genotype 1 (P07063)
NCT01390844 COMPLETED PHASE3
GS-5885 Alone or in Combination With GS-9451 With Peginterferon Alfa 2a and Ribavirin in Treatment Chronic Genotype 1 Hepatitis C Virus
NCT01356160 COMPLETED PHASE2
A Study to Evaluate the Safety and Efficacy of Celgosivir and Peginterferon Alfa-2b, With or Without Ribavirin, in Patients With Chronic Hepatitis C Genotype 1 Infection
NCT00217139 COMPLETED PHASE2
Safety Study of Pegylated Interferon Lambda Plus Single or 2 Direct Antiviral Agents With Ribavirin
NCT01309932 COMPLETED PHASE2
GS-5885, GS-9451 With Peginterferon Alfa 2a (PEG) and Ribavirin in Treatment-Naïve Subjects With Chronic Genotype 1 Hep C Virus Infection and IL28B CC Genotype
NCT01384383 TERMINATED PHASE2
A Study to Evaluate the Combination of Pegylated Interferon Alfa Plus Valopicitabine in Patients With Hepatitis C
NCT00118768 COMPLETED PHASE2
GS 5885 Administered Concomitantly With GS-9451, Tegobuvir and Ribavirin (RBV) in Chronic Genotype 1 Hepatitis C Virus (HCV) Infection
NCT01353248 COMPLETED PHASE2
4 Week Combination of BI 207127 NA With Peg-IFN and Ribavirin in Chronic HCV Patients
NCT00905632 COMPLETED PHASE1