Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Chronic Hepatitis C Drug: PPI-668 Drug: BI 207127 Dose 1 Drug: BI 207127 Dose 2 Drug: Faldaprevir Drug: Ribavirin Drug: BI 207127 Placebo Phase 2

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: 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)
Study Start Date : May 2013
Actual Primary Completion Date : May 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Ribavirin

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Active Comparator: PPI-668, BI 207127 Dose 1, Faldaprevir, and Ribavirin
PPI-668, BI 207127 Dose 1, Faldaprevir, and Ribavirin dosed in combination
 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
 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
 Drug: PPI-668
Drug: BI 207127 Dose 1
Drug: Faldaprevir


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. the proportion of patients achieving sustained viral response (SVR) [ Time Frame: 12 weeks after the end of treatment ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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

  3. 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 ]
  4. 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 ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01859962


Locations
Layout table for location information
United States, California
Quest Clinical Research
San Francisco, California, United States, 94115
Sponsors and Collaborators
Presidio Pharmaceuticals, Inc.
Boehringer Ingelheim
Investigators
Layout table for investigator information
Study Director: Nathaniel Brown, MD Presidio Pharmaceuticals, Inc.
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for additonal information
Responsible Party: Presidio Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01859962     History of Changes
Other Study ID Numbers: PPI-668-201
First Posted: May 22, 2013    Key Record Dates
Last Update Posted: November 25, 2015
Last Verified: November 2015
Keywords provided by Presidio Pharmaceuticals, Inc.:
Liver diseases
Virus diseases
Ribavirin
 protease inhibitor
NS5B polymerase inhibitor
NS5A inhibitor
Additional relevant MeSH terms:
Layout table for MeSH terms
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis
Hepatitis, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
 Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Ribavirin
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents