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

NCT ID: NCT01732796

Last Updated: 2016-04-18

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

470 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2015-01-31

Brief Summary

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The aim of the study is to confirm efficacy of treatment for 16 and 24 weeks in chronically infected HCV GT1b treatment naïve patients, including patients with compensated cirrhosis.

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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)

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Detailed Description

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Conditions

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Hepatitis C, Chronic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

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Allocated 24 weeks BI 207127 + BI 201335

24 weeks of BI 207127 and BI 201335 in combination with Ribavirin

Group Type EXPERIMENTAL

Ribavirin (RBV)

Intervention Type DRUG

24 weeks of active RBV

BI 201335 (Faldaprevir)

Intervention Type DRUG

24 weeks of BI 201335

BI 207127

Intervention Type DRUG

24 weeks of BI 207127

Randomized 16 weeks BI 7127+BI1335 + RBV

16 weeks of BI 207127 and QD BI 201335 RBV, followed by additional 8 weeks of placebo BI 207127+ placebo BI 201335 in combination with placebo RBV

Group Type EXPERIMENTAL

BI 201335 (Faldaprevir)

Intervention Type DRUG

16 weeks of BI 201335 followed by 8 weeks placebo to BI 201335

Ribavirin (RBV)

Intervention Type DRUG

16 weeks of Ribavirin followed by 8 weeks of placebo to Ribavirin

BI 207127

Intervention Type DRUG

16 weeks BI 207127 followed by 8 weeks placebo to BI 207127

Randomized 24weeks BI 7127+ BI1335 + RBV

24 weeks of BI 207127and BI 201335 in combination with RBV

Group Type EXPERIMENTAL

Ribavirin (RBV)

Intervention Type DRUG

24 weeks of active RBV

BI 207127

Intervention Type DRUG

24 weeks of BI 207127

Faldaprevir (BI 201335)

Intervention Type DRUG

24 weeks of 201335

Interventions

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Ribavirin (RBV)

24 weeks of active RBV

Intervention Type DRUG

BI 201335 (Faldaprevir)

16 weeks of BI 201335 followed by 8 weeks placebo to BI 201335

Intervention Type DRUG

Ribavirin (RBV)

24 weeks of active RBV

Intervention Type DRUG

BI 207127

24 weeks of BI 207127

Intervention Type DRUG

BI 201335 (Faldaprevir)

24 weeks of BI 201335

Intervention Type DRUG

Ribavirin (RBV)

16 weeks of Ribavirin followed by 8 weeks of placebo to Ribavirin

Intervention Type DRUG

BI 207127

16 weeks BI 207127 followed by 8 weeks placebo to BI 207127

Intervention Type DRUG

Faldaprevir (BI 201335)

24 weeks of 201335

Intervention Type DRUG

BI 207127

24 weeks of BI 207127

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Chronic hepatitis C infection, diagnosed by positive HCV Ab or detectable HCV RNA at screening in addition to at least one of the following:

1. positive HCV RNA or HCV antibodies at least 6 months prior to screening, or
2. liver biopsy typical of chronic hepatitis C , or
3. history of elevated ALT at least 6 months prior to screening.
* HCV infection of sub-GT1b confirmed by genotypic testing at screening
* Treatment naïve defined as:

1. no prior treatment with any interferon, pegylated interferon, and /or ribavirin and
2. no prior treatment with at least one dose of any other licensed or investigational antiviral agent for acute or chronic hepatitis C infection
* Plasma HCV RNA \> or = 1,000 IU/mL at screening
* Liver biopsy within three years or fibroscan within six months prior to randomization. Patients with compensated liver cirrhosis (score Child-Pugh A) could also be included.
* Age 18 to 75 years
* Female patients with a negative urine pregnancy test (dipstick) at Visit 2 prior to randomization

1. with documented hysterectomy, or
2. who have had both ovaries removed, or
3. with documented tubal ligation, or
4. who are post-menopausal with last menstrual period at least 12 months prior to screening, or
5. of childbearing potential with a negative serum pregnancy test at screening and a negative urine pregnancy test on Day 1 (Visit 2), that agree to use two non-hormonal methods of birth control from the date of screening until months after the last dose of ribavirin. They must not breast-feed at any time from the date of screening until 7 months after the last dose of ribavirin. Medically accepted methods of contraception for females in this trial are diaphragm with spermicide substance, intrauterine devices, cervical caps and condoms.

OR:

Male patients

1. who are documented to be sterile, or
2. who consistently and correctly use a condom while their female partners (if of child-bearing potential) agree to use one of the appropriate medically accepted methods of birth control from the date of screening until 7 months after the last dose of ribavirin, and
3. without pregnant female partners. It is in the responsibility of the male patient to ensure that his partner (or partners) is not pregnant prior to enrolment into the study or becomes pregnant during the treatment and follow-up phase. Female partners of childbearing potential must perform monthly pregnancy tests from the date of screening until 7 months after the last dose of ribavirin (tests will be provided by the sponsor).

Exclusion Criteria

* HCV infection of mixed genotype (1/2, 1/3, and 1/4) diagnosed by genotypic testing at screening.
* HCV subtype 1a, mixed 1a/1b or GT1 undefined
* Evidence of liver disease mainly due to causes other than chronic HCV infection such as autoimmune hepatitis, primary biliary cirrhosis, hemochromatosis or Wilson's disease
* HIV-1 or HIV-2 infection
* Hepatitis B virus (HBV) infection based on presence of HBs-Ag
* Evidence of decompensated liver disease, or history of decompensated liver disease, defined as history of ascites, hepatic encephalopathy, or bleeding esophageal varices,
* International Normalized Ratio (INR) \> or =1.7
* Serum albumin \< 3.3 g/dL
* Serum total bilirubin \>2.0 times the upper limit of normal (ULN) with direct/indirect ratio \>1, unless history of Gilbert's disease
* Active or suspected malignancy or history of malignancy within the last 5 years (with the exception of appropriately treated basal cell carcinoma of the skin or in situ carcinoma of the uterine cervix)
* Patients with ongoing or historical photosensitivity or recurrent rash
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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1241.20.00026 Boehringer Ingelheim Investigational Site

Dothan, Alabama, United States

Site Status

1241.20.00033 Boehringer Ingelheim Investigational Site

Chula Vista, California, United States

Site Status

1241.20.00006 Boehringer Ingelheim Investigational Site

La Mesa, California, United States

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1241.20.00003 Boehringer Ingelheim Investigational Site

Oceanside, California, United States

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1241.20.00008 Boehringer Ingelheim Investigational Site

Poway, California, United States

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1241.20.00015 Boehringer Ingelheim Investigational Site

Fort Lauderdale, Florida, United States

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1241.20.00014 Boehringer Ingelheim Investigational Site

Ft. Pierce, Florida, United States

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1241.20.00004 Boehringer Ingelheim Investigational Site

Maitland, Florida, United States

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1241.20.00010 Boehringer Ingelheim Investigational Site

Decatur, Georgia, United States

Site Status

1241.20.00001 Boehringer Ingelheim Investigational Site

New Orleans, Louisiana, United States

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1241.20.00018 Boehringer Ingelheim Investigational Site

Baltimore, Maryland, United States

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1241.20.00002 Boehringer Ingelheim Investigational Site

Chevy Chase, Maryland, United States

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1241.20.00032 Boehringer Ingelheim Investigational Site

Springfield, Massachusetts, United States

Site Status

1241.20.00009 Boehringer Ingelheim Investigational Site

Las Vegas, Nevada, United States

Site Status

1241.20.00016 Boehringer Ingelheim Investigational Site

New York, New York, United States

Site Status

1241.20.00031 Boehringer Ingelheim Investigational Site

New York, New York, United States

Site Status

1241.20.00019 Boehringer Ingelheim Investigational Site

Rochester, New York, United States

Site Status

1241.20.00024 Boehringer Ingelheim Investigational Site

Tulsa, Oklahoma, United States

Site Status

1241.20.00013 Boehringer Ingelheim Investigational Site

Portland, Oregon, United States

Site Status

1241.20.00005 Boehringer Ingelheim Investigational Site

Austin, Texas, United States

Site Status

1241.20.00017 Boehringer Ingelheim Investigational Site

Dallas, Texas, United States

Site Status

1241.20.00012 Boehringer Ingelheim Investigational Site

Houston, Texas, United States

Site Status

1241.20.00022 Boehringer Ingelheim Investigational Site

Houston, Texas, United States

Site Status

1241.20.00020 Boehringer Ingelheim Investigational Site

Richmond, Virginia, United States

Site Status

1241.20.43003 Boehringer Ingelheim Investigational Site

Graz, , Austria

Site Status

1241.20.01001 Boehringer Ingelheim Investigational Site

Vancouver, British Columbia, Canada

Site Status

1241.20.01008 Boehringer Ingelheim Investigational Site

Vancouver, British Columbia, Canada

Site Status

1241.20.01010 Boehringer Ingelheim Investigational Site

Vancouver, British Columbia, Canada

Site Status

1241.20.01003 Boehringer Ingelheim Investigational Site

Victoria, British Columbia, Canada

Site Status

1241.20.01006 Boehringer Ingelheim Investigational Site

Hamilton, Ontario, Canada

Site Status

1241.20.01002 Boehringer Ingelheim Investigational Site

Toronto, Ontario, Canada

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1241.20.01005 Boehringer Ingelheim Investigational Site

Whitby, Ontario, Canada

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1241.20.01007 Boehringer Ingelheim Investigational Site

Montreal, Quebec, Canada

Site Status

1241.20.33003 Boehringer Ingelheim Investigational Site

Clermont-Ferrand, , France

Site Status

1241.20.33004 Boehringer Ingelheim Investigational Site

Lyon, , France

Site Status

1241.20.33006 Boehringer Ingelheim Investigational Site

Marseille, , France

Site Status

1241.20.33001 Boehringer Ingelheim Investigational Site

Montpellier, , France

Site Status

1241.20.33005 Boehringer Ingelheim Investigational Site

Nice, , France

Site Status

1241.20.33007 Boehringer Ingelheim Investigational Site

Paris, , France

Site Status

1241.20.33002 Boehringer Ingelheim Investigational Site

Pessac, , France

Site Status

1241.20.33009 Boehringer Ingelheim Investigational Site

Rennes, , France

Site Status

1241.20.33008 Boehringer Ingelheim Investigational Site

Vandœuvre-lès-Nancy, , France

Site Status

1241.20.49002 Boehringer Ingelheim Investigational Site

Berlin, , Germany

Site Status

1241.20.49004 Boehringer Ingelheim Investigational Site

Berlin, , Germany

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1241.20.49012 Boehringer Ingelheim Investigational Site

Bonn, , Germany

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1241.20.49013 Boehringer Ingelheim Investigational Site

Cologne, , Germany

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1241.20.49001 Boehringer Ingelheim Investigational Site

Frankfurt am Main, , Germany

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1241.20.49014 Boehringer Ingelheim Investigational Site

Hamburg, , Germany

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1241.20.49009 Boehringer Ingelheim Investigational Site

Herne, , Germany

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1241.20.49008 Boehringer Ingelheim Investigational Site

Kiel, , Germany

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1241.20.49011 Boehringer Ingelheim Investigational Site

Leipzig, , Germany

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1241.20.49006 Boehringer Ingelheim Investigational Site

Magdeburg, , Germany

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1241.20.49003 Boehringer Ingelheim Investigational Site

München, , Germany

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1241.20.49010 Boehringer Ingelheim Investigational Site

Oberhausen, , Germany

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1241.20.49005 Boehringer Ingelheim Investigational Site

Ulm, , Germany

Site Status

1241.20.49007 Boehringer Ingelheim Investigational Site

Würzburg, , Germany

Site Status

1241.20.36001 Boehringer Ingelheim Investigational Site

Budapest, , Hungary

Site Status

1241.20.36002 Boehringer Ingelheim Investigational Site

Kaposvár, , Hungary

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1241.20.35301 Boehringer Ingelheim Investigational Site

Dublin, , Ireland

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1241.20.35302 Boehringer Ingelheim Investigational Site

Dublin, , Ireland

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1241.20.35303 Boehringer Ingelheim Investigational Site

Dublin, , Ireland

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1241.20.39007 Boehringer Ingelheim Investigational Site

Ancona, , Italy

Site Status

1241.20.39003 Boehringer Ingelheim Investigational Site

Brescia, , Italy

Site Status

1241.20.39002 Boehringer Ingelheim Investigational Site

Milan, , Italy

Site Status

1241.20.39008 Boehringer Ingelheim Investigational Site

Milan, , Italy

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1241.20.39006 Boehringer Ingelheim Investigational Site

Napoli, , Italy

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1241.20.39005 Boehringer Ingelheim Investigational Site

Pavia, , Italy

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1241.20.39001 Boehringer Ingelheim Investigational Site

Torino, , Italy

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1241.20.39004 Boehringer Ingelheim Investigational Site

Torino, , Italy

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1241.20.31001 Boehringer Ingelheim Investigational Site

Amsterdam, , Netherlands

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1241.20.31003 Boehringer Ingelheim Investigational Site

Amsterdam, , Netherlands

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1241.20.31004 Boehringer Ingelheim Investigational Site

Amsterdam, , Netherlands

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1241.20.31005 Boehringer Ingelheim Investigational Site

Groningen, , Netherlands

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1241.20.31006 Boehringer Ingelheim Investigational Site

The Hague, , Netherlands

Site Status

1241.20.35103 Boehringer Ingelheim Investigational Site

Aveiro, , Portugal

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1241.20.35104 Boehringer Ingelheim Investigational Site

Coimbra, , Portugal

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1241.20.35101 Boehringer Ingelheim Investigational Site

Lisbon, , Portugal

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1241.20.35102 Boehringer Ingelheim Investigational Site

Porto, , Portugal

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1241.20.35105 Boehringer Ingelheim Investigational Site

Vila Real, , Portugal

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1241.20.40001 Boehringer Ingelheim Investigational Site

Bucharest, , Romania

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1241.20.40002 Boehringer Ingelheim Investigational Site

Bucharest, , Romania

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1241.20.40003 Boehringer Ingelheim Investigational Site

Bucharest, , Romania

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1241.20.70002 Boehringer Ingelheim Investigational Site

Chelyabinsk, , Russia

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1241.20.70001 Boehringer Ingelheim Investigational Site

Moscow, , Russia

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1241.20.70004 Boehringer Ingelheim Investigational Site

Saint Petersburg, , Russia

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1241.20.70005 Boehringer Ingelheim Investigational Site

Saint Petersburg, , Russia

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1241.20.34007 Boehringer Ingelheim Investigational Site

A Coruña, , Spain

Site Status

1241.20.34004 Boehringer Ingelheim Investigational Site

Alicante, , Spain

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1241.20.34002 Boehringer Ingelheim Investigational Site

Barcelona, , Spain

Site Status

1241.20.34005 Boehringer Ingelheim Investigational Site

Barcelona, , Spain

Site Status

1241.20.34003 Boehringer Ingelheim Investigational Site

Madrid, , Spain

Site Status

1241.20.34001 Boehringer Ingelheim Investigational Site

Majadahonda, Madrid, , Spain

Site Status

1241.20.34008 Boehringer Ingelheim Investigational Site

Santander, , Spain

Site Status

1241.20.34006 Boehringer Ingelheim Investigational Site

Valencia, , Spain

Site Status

1241.20.44005 Boehringer Ingelheim Investigational Site

Bristol, , United Kingdom

Site Status

1241.20.44007 Boehringer Ingelheim Investigational Site

Liverpool, , United Kingdom

Site Status

1241.20.44001 Boehringer Ingelheim Investigational Site

London, , United Kingdom

Site Status

1241.20.44002 Boehringer Ingelheim Investigational Site

London, , United Kingdom

Site Status

1241.20.44006 Boehringer Ingelheim Investigational Site

London, , United Kingdom

Site Status

1241.20.44004 Boehringer Ingelheim Investigational Site

Nottingham, , United Kingdom

Site Status

1241.20.44003 Boehringer Ingelheim Investigational Site

Southampton, , United Kingdom

Site Status

Countries

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United States Austria Canada France Germany Hungary Ireland Italy Netherlands Portugal Romania Russia Spain United Kingdom

References

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Sarrazin C, Castelli F, Andreone P, Buti M, Colombo M, Pol S, Calinas F, Puoti M, Olveira A, Shiffman M, Stern JO, Kukolj G, Roehrle M, Aslanyan S, Deng Q, Vinisko R, Mensa FJ, Nelson DR. HCVerso1 and 2: faldaprevir with deleobuvir (BI 207127) and ribavirin for treatment-naive patients with chronic hepatitis C virus genotype-1b infection. Clin Exp Gastroenterol. 2016 Nov 24;9:351-363. doi: 10.2147/CEG.S111116. eCollection 2016.

Reference Type DERIVED
PMID: 27920566 (View on PubMed)

Other Identifiers

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2012-003533-41

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1241.20

Identifier Type: -

Identifier Source: org_study_id

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