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Trial record 6 of 12 for:    ravidasvir

Study of PPI-668, BI 207127 and Faldaprevir, With and Without Ribavirin, in the Treatment of Chronic Hepatitis C

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01859962
Recruitment Status : Completed
First Posted : May 22, 2013
Last Update Posted : November 25, 2015
Sponsor:
Collaborator:
Boehringer Ingelheim
Information provided by (Responsible Party):
Presidio Pharmaceuticals, Inc.

Tracking Information
First Submitted Date  ICMJE May 17, 2013
First Posted Date  ICMJE May 22, 2013
Last Update Posted Date November 25, 2015
Study Start Date  ICMJE May 2013
Actual Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 20, 2013)
the proportion of patients achieving sustained viral response (SVR) [ Time Frame: 12 weeks after the end of treatment ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01859962 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 20, 2013)
  • Proportion of patients with "virologic relapse" post-treatment, defined as confirmed and quantifiable (>LLOQ) serum HCV RNA in a patient who achieved non-detectable serum HCV RNA by the end of treatment [ Time Frame: up to 24 weeks post-treatment ]
  • Proportion of patients with confirmed viral breakthrough during study treatment [ Time Frame: up to 12 weeks of study treatment ]
    "Confirmed viral breakthrough" is defined as a > 1 log increase in HCV RNA from post-Baseline nadir value or confirmed increase in HCV RNA ≥LLOQ if HCV RNA previously declined to <LLOQ (detected or not detected), during the 12-week study treatment period
  • Proportions of study participants who receive at least one dose of study drug and who prematurely discontinue study treatment, and proportions prematurely discontinuing treatment for clinical adverse events or laboratory abnormalities [ Time Frame: up to 12 weeks of study treatment ]
  • Proportions of study participants experiencing treatment-emergent adverse events (serious and non-serious) considered to be possibly or probably attributable to study treatment, overall and by body system [ Time Frame: up to 12 weeks of study treatment ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of PPI-668, BI 207127 and Faldaprevir, With and Without Ribavirin, in the Treatment of Chronic Hepatitis C
Official Title  ICMJE A Phase 2a Study of PPI-668 in Combination With BI 207127 and Faldaprevir, With and Without Ribavirin, in Treatment-Naive Patients With Chronic Hepatitis C (HCV Genotype 1a)
Brief Summary This study is designed to provide a preliminary assessment of the safety and effectiveness of the combination of PPI-668, BI 207127 and faldaprevir, with or without ribavirin, in the treatment of chronic hepatitis C virus infection.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Chronic Hepatitis C
Intervention  ICMJE
  • Drug: PPI-668
  • Drug: BI 207127 Dose 1
  • Drug: BI 207127 Dose 2
  • Drug: Faldaprevir
  • Drug: Ribavirin
  • Drug: BI 207127 Placebo
Study Arms  ICMJE
  • Active Comparator: PPI-668, BI 207127 Dose 1, Faldaprevir, and Ribavirin
    PPI-668, BI 207127 Dose 1, Faldaprevir, and Ribavirin dosed in combination
    Interventions:
    • Drug: PPI-668
    • Drug: BI 207127 Dose 1
    • Drug: Faldaprevir
    • Drug: Ribavirin
  • Active Comparator: PPI-668, BI 207127 Dose 2, Faldaprevir, and Ribavirin
    PPI-668, BI 207127 Dose 2, BI 207127 Placebo, Faldaprevir, and Ribavirin dosed in combination
    Interventions:
    • Drug: PPI-668
    • Drug: BI 207127 Dose 2
    • Drug: Faldaprevir
    • Drug: Ribavirin
    • Drug: BI 207127 Placebo
  • Active Comparator: PPI-668, BI 207127 Dose 1, and Faldaprevir
    PPI-668, BI 207127 Dose 1, and Faldaprevir dosed in combination
    Interventions:
    • Drug: PPI-668
    • Drug: BI 207127 Dose 1
    • Drug: Faldaprevir
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 20, 2015)
38
Original Estimated Enrollment  ICMJE
 (submitted: May 20, 2013)
36
Actual Study Completion Date  ICMJE December 2014
Actual Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Male or female, 18 to 65 years of age; if females are of childbearing potential, then they must be willing to use two non-hormonal methods of birth control
  2. Body weight greater than 40 kg and less than 125 kg
  3. Clinical diagnosis of chronic hepatitis C
  4. Treatment-naïve for hepatitis C: no previous treatment with interferon, pegylated interferon, ribavirin, telaprevir, boceprevir, or any investigational therapies for hepatitis C
  5. No symptoms or signs of intercurrent illness at Screen (other than those attributable to hepatitis C)
  6. No clinically significant abnormalities in the 12-lead electrocardiogram at Screen
  7. Signed informed consent prior to trial participation.

Exclusion Criteria:

  1. Seropositive for HIV antibody or Hepatitis B Surface Antigen at Screen
  2. Liver disease due to causes other than chronic HCV infection
  3. Symptoms or signs of decompensated liver disease, or evidence of cirrhosis
  4. Any medical condition that may interfere with the absorption, distribution or elimination of study drugs
  5. Poorly controlled or unstable hypertension at Screen.
  6. Clinically significant, unstable cardiovascular or pulmonary disease, including cardiovascular or pulmonary disease requiring pharmacologic intervention other than anti-hypertensive medications, statins, and/or prophylactic aspirin (or similar anticoagulant).
  7. Red blood cell disorder, including (but not limited to): thalassemia major or minor, sickle cell anemia.
  8. Diabetes Mellitus treated with insulin or hypoglycemic agents
  9. History of asthma requiring hospital admission within the preceding 12 months
  10. History of alcohol abuse or illicit drug use which could interfere with a patient's compliance with the protocol requirements, or with the safety or efficacy assessments in this study
  11. Patients requiring treatment, during this study, with any of the medications on the restricted medications list (provided in the investigator site file), are not eligible for this study due to considerations of possible drug interactions with the study drug regimen.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01859962
Other Study ID Numbers  ICMJE PPI-668-201
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Presidio Pharmaceuticals, Inc.
Study Sponsor  ICMJE Presidio Pharmaceuticals, Inc.
Collaborators  ICMJE Boehringer Ingelheim
Investigators  ICMJE
Study Director: Nathaniel Brown, MD Presidio Pharmaceuticals, Inc.
PRS Account Presidio Pharmaceuticals, Inc.
Verification Date November 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP