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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Boehringer Ingelheim
Information provided by (Responsible Party):
Presidio Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01859962
First received: May 17, 2013
Last updated: January 30, 2014
Last verified: January 2014

May 17, 2013
January 30, 2014
May 2013
May 2014   (final data collection date for primary outcome measure)
the proportion of patients achieving sustained viral response (SVR) [ Time Frame: 12 weeks after the end of treatment ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01859962 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • Proportion of patients with confirmed viral breakthrough during study treatment [ Time Frame: up to 12 weeks of study treatment ] [ Designated as safety issue: No ]
    "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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Study of PPI-668, BI 207127 and Faldaprevir, With and Without Ribavirin, in the Treatment of Chronic Hepatitis C
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)

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Chronic Hepatitis C
  • Drug: PPI-668
  • Drug: BI 207127 Dose 1
  • Drug: BI 207127 Dose 2
  • Drug: Faldaprevir
  • Drug: Ribavirin
  • Drug: BI 207127 Placebo
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
36
August 2014
May 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01859962
PPI-668-201
No
Presidio Pharmaceuticals, Inc.
Presidio Pharmaceuticals, Inc.
Boehringer Ingelheim
Study Director: Nathaniel Brown, MD Presidio Pharmaceuticals, Inc.
Presidio Pharmaceuticals, Inc.
January 2014

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