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 Phase 3 Results

• 2 other identifiers: 1220.302010-021716-42
• Study Type: interventional
• Target: 656
• Locations: 11 countries
• Sites: 98

Brief Summary

The objective of this trial is to evaluate the efficacy and safety of two different treatment regimens with BI 201335, both in combination with PegIFN/RBV) as compared to standard of care (SOC) with PegIFN/RBV alone.

Conditions

Hepatitis C

Outcome Measures

Primary Outcomes (1)

• Sustained Virological Response 12 Weeks Post-treatment (SVR12)

  Sustained Virological Response 12 weeks post-treatment (SVR12), defined as plasma Hepatitis C virus (HCV) Ribonucleic acid (RNA) level \< 25 IU/mL (undetected) 12 weeks after the originally planned treatment duration.

  12 weeks post treatment, up to 60 weeks

Secondary Outcomes (10)

• Sustained Virological Response 24 Weeks Post-treatment (SVR24)

  24 weeks post treatment, up to 72 weeks

• Early Treatment Success (ETS)

  week 4 and week 8

• Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at End of Treatment (EoT) When SVR12=YES

  12 weeks post treatment, up to 60 weeks

• Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at End of Treatment (EoT) When SVR12= NO

  12 weeks post treatment, up to 60 weeks

• Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=YES

  12 weeks post treatment, up to 60 weeks

Study Arms (3)

PegIFN/RBV

ACTIVE COMPARATOR

PegIFN/RBV for 48 weeks

Drug: PegIFN/RBV

BI 201335 for 12 or 24 weeks

EXPERIMENTAL

BI 201335 once daily low dose for 12 or 24 weeks in combination with PegIFN/RBV for 24 or 48 weeks

Drug: PegIFN/RBV; Drug: BI 201335

Placebo and PegIFN/RBV

ACTIVE COMPARATOR

Placebo (oral) once daily plus PegIFN/RBV (subcutaneous injection/oral) for 24 weeks, followed by PegIFN/RBV alone up to Week 48.

Drug: PegIFN/RBV; Drug: Placebo

Interventions

PegIFN/RBV DRUG

PegIFN/RBV for 48 weeks

BI 201335 for 12 or 24 weeks; PegIFN/RBV; Placebo and PegIFN/RBV

BI 201335 DRUG

BI 201335 once daily high dose

BI 201335 for 12 or 24 weeks

Placebo DRUG

Placebo and PegIFN/RBV

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Chronic hepatitis C infection, diagnosed by positive anti-HCV antibodies and detected HCV RNA at screening in addition to:
• positive anti-HCV antibodies or detected HCV RNA at least 6 months prior to screening; or,
• liver biopsy consistent with chronic HCV infection.
• HCV genotype 1 infection confirmed by genotypic testing at screening.
• Therapy-naïve to interferon, pegylated interferon, ribavirin or any antiviral / immunomodulatory drug for acute or chronic HCV infection.
• HCV RNA = 1,000 IU/mL at screening
• Documentation of a liver biopsy within 3 years or fibroscan within 6 months prior to randomization.
• Note: If cirrhosis has been previously demonstrated on a biopsy, then biopsies obtained more than 3 years before randomization need not be repeated. Biopsies may be waived for patients who would be placed at risk from the procedure. Inability to do a liver biopsy in patients at risk for the procedure should not exclude such patients from a trial.
• Age 18 to 70 years
• Female patients:
• with documented hysterectomy,
• who have had both ovaries removed,
• with documented tubal ligation,
• who are post-menopausal with last menstrual period at least 12 months prior to screening, or
• of childbearing potential with a negative serum pregnancy test at screening and Day 1, that, if sexually active, 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 in addition to the consistent and correct use of a condom. Patients must agree not to breast-feed at any time from the date of screening until 7 months after the last dose of ribavirin.

You may not qualify if:

• HCV infection of mixed genotype (1/2, 1/3, and 1/4) diagnosed by genotypic testing at screening
• HIV co-infection
• Hepatitis B virus (HBV) infection based on presence of HBs-Ag
• Active malignancy, or history of malignancy within the last 5 years prior to screening (with an exception of appropriately treated basal cell carcinoma of the skin or in situ carcinoma of the uterine cervix)
• Active or, history of alcohol or illicit drug abuse other than cannabis within the past 12 months
• A condition that is defined as one which in the opinion of investigator may put the patient at risk because of participation in this study, may influence the results of this study, or limit the patients ability to participate in this study
• Usage of any investigational drugs within 30 days prior to screening, or planned usage of an investigational drug during the course of this study.
• Received concomitant systemic antiviral, hematopoietic growth factor, or immunomodulatory treatment within 30 days prior to randomization. Patients being treated with oral antivirals such as acyclovir, famciclovir or valacyclovir for recurrent herpes simplex infection; or with oseltamivir or zanamivir for influenza A infection, may be screened.
• Received silymarin (milk thistle), glycyrrhizin, or Sho-saiko-to (SST) within 28 days prior to randomization and throughout the treatment phase of this trial.
• Known hypersensitivity to any ingredient of the study drugs.
• Alpha fetoprotein value \> 100 ng/mL at screening; if \> 20 ng/mL and = 100 ng/mL, patients may be included if there is no evidence of liver cancer in an appropriate imaging study (e.g., ultrasound, CT scan, or MRI) within last 6 months prior to randomization (Visit 2).

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (98)

1220.30.4303 Boehringer Ingelheim Investigational Site

Linz, Austria

Location

1220.30.4301 Boehringer Ingelheim Investigational Site

Vienna, Austria

Location

1220.30.4302 Boehringer Ingelheim Investigational Site

Vienna, Austria

Location

1220.30.4304 Boehringer Ingelheim Investigational Site

Vienna, Austria

Location

1220.30.3201 Boehringer Ingelheim Investigational Site

Brussels, Belgium

Location

1220.30.3207 Boehringer Ingelheim Investigational Site

Brussels, Belgium

Location

1220.30.3204 Boehringer Ingelheim Investigational Site

Edegem, Belgium

Location

1220.30.3205 Boehringer Ingelheim Investigational Site

Ghent, Belgium

Location

1220.30.3202 Boehringer Ingelheim Investigational Site

Leuven, Belgium

Location

1220.30.3203 Boehringer Ingelheim Investigational Site

Liège, Belgium

Location

1220.30.3314 Boehringer Ingelheim Investigational Site

Clermont-Ferrand, France

Location

1220.30.3301 Boehringer Ingelheim Investigational Site

Clichy, France

Location

1220.30.3311 Boehringer Ingelheim Investigational Site

Lille, France

Location

1220.30.3303 Boehringer Ingelheim Investigational Site

Marseille, France

Location

1220.30.3304 Boehringer Ingelheim Investigational Site

Montpellier, France

Location

1220.30.3305 Boehringer Ingelheim Investigational Site

Nice, France

Location

1220.30.3302 Boehringer Ingelheim Investigational Site

Paris, France

Location

1220.30.3309 Boehringer Ingelheim Investigational Site

Paris, France

Location

1220.30.3316 Boehringer Ingelheim Investigational Site

Pessac, France

Location

1220.30.3315 Boehringer Ingelheim Investigational Site

Rennes, France

Location

1220.30.3312 Boehringer Ingelheim Investigational Site

Saint-Laurent-du-Var, France

Location

1220.30.3313 Boehringer Ingelheim Investigational Site

Toulouse, France

Location

1220.30.4917 Boehringer Ingelheim Investigational Site

Aachen, Germany

Location

1220.30.4902 Boehringer Ingelheim Investigational Site

Berlin, Germany

Location

1220.30.4904 Boehringer Ingelheim Investigational Site

Berlin, Germany

Location

1220.30.4916 Boehringer Ingelheim Investigational Site

Bonn, Germany

Location

1220.30.4913 Boehringer Ingelheim Investigational Site

Dortmund, Germany

Location

1220.30.4906 Boehringer Ingelheim Investigational Site

Düsseldorf, Germany

Location

1220.30.4909 Boehringer Ingelheim Investigational Site

Düsseldorf, Germany

Location

1220.30.4912 Boehringer Ingelheim Investigational Site

Erlangen, Germany

Location

1220.30.4901 Boehringer Ingelheim Investigational Site

Frankfurt am Main, Germany

Location

1220.30.4908 Boehringer Ingelheim Investigational Site

Hamburg, Germany

Location

1220.30.4907 Boehringer Ingelheim Investigational Site

Herne, Germany

Location

1220.30.4914 Boehringer Ingelheim Investigational Site

Kiel, Germany

Location

1220.30.4903 Boehringer Ingelheim Investigational Site

Leipzig, Germany

Location

1220.30.4911 Boehringer Ingelheim Investigational Site

Mainz, Germany

Location

1220.30.4905 Boehringer Ingelheim Investigational Site

München, Germany

Location

1220.30.4915 Boehringer Ingelheim Investigational Site

Ulm, Germany

Location

1220.30.8106 Boehringer Ingelheim Investigational Site

Chiba, Chiba, Japan

Location

1220.30.8111 Boehringer Ingelheim Investigational Site

Gifu, Gifu, Japan

Location

1220.30.8107 Boehringer Ingelheim Investigational Site

Itabashi-ku, Tokyo, Japan

Location

1220.30.8112 Boehringer Ingelheim Investigational Site

Izunokuni, Shizuoka, Japan

Location

1220.30.8108 Boehringer Ingelheim Investigational Site

Kamakura, Kanagawa, Japan

Location

1220.30.8117 Boehringer Ingelheim Investigational Site

Kita-gun, Kagawa, Japan

Location

1220.30.8109 Boehringer Ingelheim Investigational Site

Kofu, Yamanashi, Japan

Location

1220.30.8116 Boehringer Ingelheim Investigational Site

Kurashiki, Okayama, Japan

Location

1220.30.8118 Boehringer Ingelheim Investigational Site

Kurume, Fukuoka, Japan

Location

1220.30.8110 Boehringer Ingelheim Investigational Site

Matsumoto, Nagano, Japan

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1220.30.8113 Boehringer Ingelheim Investigational Site

Nagoya, Aichi, Japan

Location

1220.30.8105 Boehringer Ingelheim Investigational Site

Namegata, Ibaraki, Japan

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1220.30.8114 Boehringer Ingelheim Investigational Site

Nishinomiya, Hyogo, Japan

Location

1220.30.8119 Boehringer Ingelheim Investigational Site

Omura, Nagasaki, Japan

Location

1220.30.8122 Boehringer Ingelheim Investigational Site

Omuta, Fukuoka, Japan

Location

1220.30.8121 Boehringer Ingelheim Investigational Site

Osaka, Osaka, Japan

Location

1220.30.8101 Boehringer Ingelheim Investigational Site

Sapporo, Hokkaido, Japan

Location

1220.30.8102 Boehringer Ingelheim Investigational Site

Sendai, Miyagi, Japan

Location

1220.30.8115 Boehringer Ingelheim Investigational Site

Tanabe, Wakayama, Japan

Location

1220.30.8104 Boehringer Ingelheim Investigational Site

Tsuchiura, Ibaraki, Japan

Location

1220.30.3503 Boehringer Ingelheim Investigational Site

Aveiro, Portugal

Location

1220.30.3509 Boehringer Ingelheim Investigational Site

Barreiro, Portugal

Location

1220.30.3506 Boehringer Ingelheim Investigational Site

Coimbra, Portugal

Location

1220.30.3501 Boehringer Ingelheim Investigational Site

Lisbon, Portugal

Location

1220.30.3505 Boehringer Ingelheim Investigational Site

Lisbon, Portugal

Location

1220.30.3507 Boehringer Ingelheim Investigational Site

Lisbon, Portugal

Location

1220.30.3502 Boehringer Ingelheim Investigational Site

Porto, Portugal

Location

1220.30.3504 Boehringer Ingelheim Investigational Site

Vila Real, Portugal

Location

1220.30.4001 Boehringer Ingelheim Investigational Site

Bucharest, Romania

Location

1220.30.4002 Boehringer Ingelheim Investigational Site

Bucharest, Romania

Location

1220.30.4003 Boehringer Ingelheim Investigational Site

Bucharest, Romania

Location

1220.30.4004 Boehringer Ingelheim Investigational Site

Bucharest, Romania

Location

1220.30.7002 Boehringer Ingelheim Investigational Site

Chelyabinsk, Russia

Location

1220.30.7001 Boehringer Ingelheim Investigational Site

Moscow, Russia

Location

1220.30.7004 Boehringer Ingelheim Investigational Site

Moscow, Russia

Location

1220.30.7005 Boehringer Ingelheim Investigational Site

Moscow, Russia

Location

1220.30.7006 Boehringer Ingelheim Investigational Site

Saint Petersburg, Russia

Location

1220.30.7007 Boehringer Ingelheim Investigational Site

Saint Petersburg, Russia

Location

1220.30.3406 Boehringer Ingelheim Investigational Site

A Coruña, Spain

Location

1220.30.3402 Boehringer Ingelheim Investigational Site

Barcelona, Spain

Location

1220.30.3404 Boehringer Ingelheim Investigational Site

Barcelona, Spain

Location

1220.30.3405 Boehringer Ingelheim Investigational Site

Madrid, Spain

Location

1220.30.3408 Boehringer Ingelheim Investigational Site

Santander, Spain

Location

1220.30.3403 Boehringer Ingelheim Investigational Site

Seville, Spain

Location

1220.30.3401 Boehringer Ingelheim Investigational Site

Valencia, Spain

Location

1220.30.3407 Boehringer Ingelheim Investigational Site

Vigo (Pontevedra), Spain

Location

1220.30.4106 Boehringer Ingelheim Investigational Site

Bern, Switzerland

Location

1220.30.4103 Boehringer Ingelheim Investigational Site

La Chaux-de-Fonds, Switzerland

Location

1220.30.4107 Boehringer Ingelheim Investigational Site

Lugano, Switzerland

Location

1220.30.4108 Boehringer Ingelheim Investigational Site

Sankt Gallen, Switzerland

Location

1220.30.4101 Boehringer Ingelheim Investigational Site

Zurich, Switzerland

Location

1220.30.4405 Boehringer Ingelheim Investigational Site

Bristol, United Kingdom

Location

1220.30.4404 Boehringer Ingelheim Investigational Site

London, United Kingdom

Location

1220.30.4409 Boehringer Ingelheim Investigational Site

London, United Kingdom

Location

1220.30.4410 Boehringer Ingelheim Investigational Site

London, United Kingdom

Location

1220.30.4401 Boehringer Ingelheim Investigational Site

Manchester, United Kingdom

Location

1220.30.4408 Boehringer Ingelheim Investigational Site

Nottingham, United Kingdom

Location

1220.30.4407 Boehringer Ingelheim Investigational Site

Oxford, United Kingdom

Location

1220.30.4403 Boehringer Ingelheim Investigational Site

Southampton, United Kingdom

Location

1220.30.4406 Boehringer Ingelheim Investigational Site

Whitechapel, London, United Kingdom

Location

Related Publications (3)

• Jensen DM, Asselah T, Dieterich D, Foster GR, Sulkowski MS, Zeuzem S, Mantry P, Yoshida EM, Moreno C, Ouzan D, Wright M, Morano LE, Buynak R, Bourliere M, Hassanein T, Nishiguchi S, Kao JH, Omata M, Paik SW, Wong DK, Tam E, Kaita K, Feinman SV, Stern JO, Scherer J, Quinson AM, Voss F, Gallivan JP, Bocher WO, Ferenci P. Faldaprevir, pegylated interferon, and ribavirin for treatment-naive HCV genotype-1: pooled analysis of two phase 3 trials. Ann Hepatol. 2016 May-Jun;15(3):333-49. doi: 10.5604/16652681.1198803.

  PMID: 27049487 DERIVED

• Dieterich D, Nelson M, Soriano V, Arasteh K, Guardiola JM, Rockstroh JK, Bhagani S, Laguno M, Tural C, Ingiliz P, Jain MK, Stern JO, Manero M, Vinisko R, Kort J; STARTVerso4 study group. Faldaprevir and pegylated interferon alpha-2a/ribavirin in individuals co-infected with hepatitis C virus genotype-1 and HIV. AIDS. 2015 Mar 13;29(5):571-81. doi: 10.1097/QAD.0000000000000579.

  PMID: 25710287 DERIVED

• Ferenci P, Asselah T, Foster GR, Zeuzem S, Sarrazin C, Moreno C, Ouzan D, Maevskaya M, Calinas F, Morano LE, Crespo J, Dufour JF, Bourliere M, Agarwal K, Forton D, Schuchmann M, Zehnter E, Nishiguchi S, Omata M, Kukolj G, Datsenko Y, Garcia M, Scherer J, Quinson AM, Stern JO; STARTVerso1 Study Group. STARTVerso1: A randomized trial of faldaprevir plus pegylated interferon/ribavirin for chronic HCV genotype-1 infection. J Hepatol. 2015 Jun;62(6):1246-55. doi: 10.1016/j.jhep.2014.12.024. Epub 2015 Jan 2.

  PMID: 25559324 DERIVED

MeSH Terms

Conditions

Hepatitis C

Interventions

faldaprevir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2011
• First Posted: April 28, 2011
• Study Start: April 1, 2011
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: September 18, 2015
• Results First Posted: September 18, 2015

Record last verified: 2015-08

Locations

CH (5); BE (6); RU (6); ES (8); AU (4); PT (8); JP (20); DE (16); RO (4); GB (9); FR (12)