Open Label Trial to Compare BI 207127 to Telaprevir in HCV Patients

NCT01858961 | Withdrawn Phase 3

• 2 other identifiers: 1241.372012-004544-30
• Study Type: interventional
• Target: N/A
• Locations: 3 countries
• Sites: 12

Brief Summary

The aim of this trial is to evaluate efficacy and safety of treatment with 600 mg of BID BI 207127 in combination with 120 mg QD Faldaprevir and RBV compared to a Telaprevir-based regimen along with PegIFN and RBV in chronically infected HCV GT1 treatment naïve patients, including patients with compensated cirrhosis.

Conditions

Hepatitis C, Chronic

Outcome Measures

Primary Outcomes (1)

• Sustained Virologic Response at Week 12 after end of treatment (SVR12)

  at week 12 post treatment

Secondary Outcomes (19)

• SVR4: Plasma HCV RNA level <25 IU/mL1 at 4 weeks after end of treatment

  at week 4 post treatment

• SVR24: Plasma HCV RNA level <25 IU/mL1 at 24 weeks after end of treatment

  at week 4 post treatment

• Virological Response at Week 4 -Plasma HCV RNA level undetectable at Week 4 -Plasma HCV RNA level <25 IU/mL at Week 4

  at week 4 post treatment

• Plasma HCV level undetectable at Week 12

  at week 12

• Time to achieving HCV RNA undetectable

  up to week 48

Study Arms (2)

Group 1

EXPERIMENTAL

BI 201335 in combination with BI 207127 and ribavirin for 24 weeks

Drug: BI 201335; Drug: ribavirin; Drug: BI 207127

Group 2

EXPERIMENTAL

Telaprevir in combination with PegIFN and ribavirin for 24 weeks or 48 weeks

Drug: Telaprevir; Drug: ribavirin; Drug: Pegylated Interferon

Interventions

BI 201335 DRUG

Once a day

Group 1

ribavirin DRUG

Twice a day

Group 1

BI 207127 DRUG

Twice a day

Group 1

Telaprevir DRUG

Three times a day

Group 2

Pegylated Interferon DRUG

Once a week

Group 2

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 HCV, diagnosed by HCV RNA = 1,000 IU/mL at screening in addition to at least one of the following:
• positive anti-HCV antibodies or detected HCV RNA at least 6 months prior to screening, OR
• liver biopsy indicating chronic HCV infection, OR
• history of elevated ALT levels at least 6 months prior to screening.
• HCV infection of sub-GT1b confirmed by genotypic testing at screening.
• Treatment naïve defined as:
• no prior treatment with any interferon, pegylated interferon, and /or ribavirin and
• no prior treatment with at least one dose of any other licensed or investigational antiviral agent for acute or chronic hepatitis C infection.
• Availability of a liver biopsy within three years or fibroscan within 6 months prior to randomisation.
• Age 18 - 70 years (inclusive).
• Female patients
• with documented hysterectomy, or
• who have had both ovaries removed, or
• with documented tubal ligation, or
• who are post-menopausal with last menstrual period at least 12 months prior to screening, or

You may not qualify if:

• HCV infection of mixed genotype (1/2, 1/3, and 1/4), HCV sub-GT1a or GT1 undefined, diagnosed at screening by genotypic testing.
• Liver disease due to causes other than chronic HCV infection which may include but is not limited to hemochromatosis, Wilson's disease, or autoimmune liver disease.
• HIV infection.
• Hepatitis B virus (HBV) infection based on presence of Hepatitis B surface antigen.
• Evidence of decompensated liver disease or history of decompensated liver disease, defined as history of ascites, hepatic encephalopathy, bleeding esophageal varices or any other evidence of previous decompensation and/or any laboratory results (International Normalised Ratio, albumin, bilirubin) indicating a Child-Pugh-Turcotte score \> 6 points (i.e. CPT-B or -C)
• Confirmed or suspected active 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.
• History of illicit drug use (other than cannabis) or chronic alcohol abuse within 12 months prior to randomization, in the opinion of the Investigator.
• Body mass index \<18 or \>35 kg/m2.
• Usage of any investigational drugs within 28 days prior to randomisation, or the planned usage of an investigational drug during the course of the current study.
• Known hypersensitivity to any ingredient of the study drugs.
• A condition that is insufficiently diagnosed, treated or clinically unstable which in the opinion of Investigator may put the patient at risk because of participation in this study, influence the results of this study, or limit the patient's ability to participate in this study.
• Alpha fetoprotein value \>100ng/mL at screening; if \> 20ng/mL and = 100ng/mL, patients can be included if there is no evidence of liver cancer in an appropriate imaging study within 6 months prior to randomisation.
• A history of severe pre-existing cardiac disease, including unstable or uncontrolled cardiac disease (e.g. congestive heart failure, myocardial infarction, unstable angina and arrhythmic disorders) current or within the previous 12 months before randomisation. Clinically significant Electrocardiogram (ECG) abnormalities. A history of congenital QT prolongation, or a family history of congenital QT prolongation or sudden death.
• Received silymarin (milk thistle) or glycyrrhizin or Sho-saiko-to (SST) within 28 days prior to randomisation or any medication listed in a restricted medication list provided in ISF within 28 days prior to randomisation, with the exception of parenteral analgesics used during liver biopsy procedure.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (12)

1241.37.61002 Boehringer Ingelheim Investigational Site

Westmead, New South Wales, Australia

Location

1241.37.61001 Boehringer Ingelheim Investigational Site

Adelaide, South Australia, Australia

Location

1241.37.61003 Boehringer Ingelheim Investigational Site

Fitzroy, Victoria, Australia

Location

1241.37.34010 Boehringer Ingelheim Investigational Site

Alzira, Spain

Location

1241.37.34005 Boehringer Ingelheim Investigational Site

Barcelona, Spain

Location

1241.37.34002 Boehringer Ingelheim Investigational Site

L'Hospitalet Llobregat (bcn), Spain

Location

1241.37.34001 Boehringer Ingelheim Investigational Site

Madrid, Spain

Location

1241.37.34003 Boehringer Ingelheim Investigational Site

Madrid, Spain

Location

1241.37.34004 Boehringer Ingelheim Investigational Site

Madrid, Spain

Location

1241.37.34006 Boehringer Ingelheim Investigational Site

Valencia, Spain

Location

1241.37.46002 Boehringer Ingelheim Investigational Site

Lund, Sweden

Location

1241.37.46001 Boehringer Ingelheim Investigational Site

Stockholm, Sweden

Location

MeSH Terms

Conditions

Hepatitis C, Chronic

Interventions

faldaprevir; Ribavirin; deleobuvir; telaprevir

Condition Hierarchy (Ancestors)

Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2013
• First Posted: May 21, 2013
• Study Start: May 1, 2013
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: January 23, 2014

Record last verified: 2014-01

Locations

AU (3); ES (7); SE (2)