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)
This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Boehringer Ingelheim Pharmaceuticals
First received: February 15, 2011
Last updated: May 15, 2013
Last verified: May 2013
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.
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
||A Phase III, Randomized, Double Blind and Placebo Controlled Study of Once Daily BI 201335 120 mg for 24 Weeks and BI 201335 240 mg for 12 Weeks in Combination With Pegylated Interferon Alpha and Ribavirin in Treatment Naive Patients With Genotype 1 Chronic Hepatitis C Infection.
Primary Outcome Measures:
- 1. Sustained Virological Response (SVR): Plasma HCV RNA level <25 IU/mL, undetected 24 weeks after the originally planned treatment duration. [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
- 2. Occurrence of adverse events (overall, and classified into mild/moderate/severe) [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
- 3. Occurrence of adverse events leading to treatment discontinuation [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
- 4. Occurrence of Serious Adverse Events (SAEs) [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
- 5. Occurrence of drug-related adverse events as assessed by the investigator [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
- 6. Occurrence of laboratory test abnormalities [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
- 7. Central tendency and changes from baseline in laboratory test values over time [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- 8. Virological response after 12 weeks of treatment discontinuation (SVR12): - Plasma HCV RNA level < 25 IU/mL, undetected 12 weeks after the originally planned treatment duration. [ Time Frame: 36 weeks ] [ Designated as safety issue: No ]
- 9. Early Treatment Success (ETS): - Plasma HCV RNA level < 25 IU/mL (detected or undetected) at Week 4 and HCV RNA < 25 IU/mL, undetected at Week 8. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- 10. ALT normalization: (alanine aminotransferase) in normal range 24 weeks after the end of the originally planned treatment duration. [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||April 2014 (Final data collection date for primary outcome measure)
Active Comparator: PegIFN/RBV
48 weeks standard of care
Experimental: BI 201335 for 24 weeks
BI 201 335 QD dosing in combination with IFN/RBV
QD (once daily) BI 201335
Experimental: BI201335 for 12 weeks
BI 201335 QD doing in combination with PEFG IFN/RBV
QD BI 201335
|Ages Eligible for Study:
||18 Years to 70 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
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 of the screening visit.
Note: If cirrhosis has been previously demonstrated on a biopsy, then biopsies obtained more than 3 years before enrolment need not be repeated. Biopsies can be waived for patients who would be placed at risk from the procedure. Inability to do a liver biopsy should not exclude patients from a trial.
- Age 18 to 70 years
(c) with documented hysterectomy, (d) who have had both ovaries removed, (e) with documented tubal ligation, (f) who are post-menopausal with last menstrual period at least 12 months prior to screening, or (g) 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.
Medically accepted methods of contraception for females in this trial are ethinyl estradiol-containing contraceptives, diaphragm with spermicide substance and intra-uterine device.
- who are documented to be sterile, or
- who are without pregnant female partner(s) and consistently and correctly use a condom while their female partner(s) (if of child-bearing potential) 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. It is in the responsibility of the male patient to ensure that his partner(s) is not pregnant prior to screening into the study or becomes pregnant during the treatment and the observation phase.
- Signed informed consent form prior to trial participation
- HCV infection of mixed genotype (1/2, 1/3, and 1/4) diagnosed by genotypic testing at screening.
- Evidence of acute or chronic liver disease due to causes other than chronic HCV infection.
- 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 patient¿s ability to participate in this study.
- Usage of any investigational drugs within 28 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 28 days prior to screening. 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 screening and throughout the treatment phase.
- 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).
Decompensated liver disease, or history of decompensated liver disease, as defined by the presence of: hepatic encephalopathy, ascites, or esophageal variceal bleeding and/or laboratory results of any of the following:
- International normalized ratio (INR) of =1.7
- Serum Albumin =3.5 g/dL
- Serum total bilirubin =2.0 mg/dL (except when the increase is predominately due to unconjugated bilirubin and related to Gilberts syndrome).
- Pre-existing psychiatric condition that could interfere with the subject¿s participation in and completion of the study including but not limited to prior suicidal attempt, schizophrenia, major depression syndrome, severe anxiety, severe personality disorder, a period of disability or impairment due to a psychiatric disease within the past 5 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01297270
Boehringer Ingelheim Pharmaceuticals
||Boehringer Ingelheim Pharmaceuticals
No publications provided
||Boehringer Ingelheim Pharmaceuticals
History of Changes
|Other Study ID Numbers:
|Study First Received:
||February 15, 2011
||May 15, 2013
||Canada: Health Canada
South Korea: Ministry of Food and Drug Safety (MFDS)
United States: Food and Drug Administration
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on May 16, 2013
Hepatitis C, Chronic
Digestive System Diseases
Hepatitis, Viral, Human
RNA Virus Infections
Physiological Effects of Drugs
Angiogenesis Modulating Agents
Molecular Mechanisms of Pharmacological Action