Study of PPI-668, BI 207127 and Faldaprevir, With and Without Ribavirin, in the Treatment of Chronic Hepatitis C
This study has been completed.
Sponsor:
Presidio Pharmaceuticals, Inc.
Collaborator:
Boehringer Ingelheim
Information provided by (Responsible Party):
Presidio Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01859962
First received: May 17, 2013
Last updated: November 24, 2015
Last verified: November 2015
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Purpose
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 | Intervention | 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 Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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) |
Resource links provided by NLM:
Further study details as provided by Presidio Pharmaceuticals, Inc.:
Primary Outcome Measures:
- the proportion of patients achieving sustained viral response (SVR) [ Time Frame: 12 weeks after the end of treatment ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ]
| Enrollment: | 38 |
| Study Start Date: | May 2013 |
| Study Completion Date: | December 2014 |
| Primary Completion Date: | May 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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 |
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
- Body weight greater than 40 kg and less than 125 kg
- Clinical diagnosis of chronic hepatitis C
- Treatment-naïve for hepatitis C: no previous treatment with interferon, pegylated interferon, ribavirin, telaprevir, boceprevir, or any investigational therapies for hepatitis C
- No symptoms or signs of intercurrent illness at Screen (other than those attributable to hepatitis C)
- No clinically significant abnormalities in the 12-lead electrocardiogram at Screen
- Signed informed consent prior to trial participation.
Exclusion Criteria:
- Seropositive for HIV antibody or Hepatitis B Surface Antigen at Screen
- Liver disease due to causes other than chronic HCV infection
- Symptoms or signs of decompensated liver disease, or evidence of cirrhosis
- Any medical condition that may interfere with the absorption, distribution or elimination of study drugs
- Poorly controlled or unstable hypertension at Screen.
- 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).
- Red blood cell disorder, including (but not limited to): thalassemia major or minor, sickle cell anemia.
- Diabetes Mellitus treated with insulin or hypoglycemic agents
- History of asthma requiring hospital admission within the preceding 12 months
- 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
- 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
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, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01859962
Please refer to this study by its ClinicalTrials.gov identifier: NCT01859962
Locations
| United States, California | |
| Quest Clinical Research | |
| San Francisco, California, United States, 94115 | |
Sponsors and Collaborators
Presidio Pharmaceuticals, Inc.
Boehringer Ingelheim
Investigators
| Study Director: | Nathaniel Brown, MD | Presidio Pharmaceuticals, Inc. |
More Information
| Responsible Party: | Presidio Pharmaceuticals, Inc. |
| ClinicalTrials.gov Identifier: | NCT01859962 History of Changes |
| Other Study ID Numbers: | PPI-668-201 |
| Study First Received: | May 17, 2013 |
| Last Updated: | November 24, 2015 |
| Health Authority: | United States: Food and Drug Administration United States: Institutional Review Board |
Keywords provided by Presidio Pharmaceuticals, Inc.:
|
Liver diseases Virus diseases Ribavirin |
protease inhibitor NS5B polymerase inhibitor NS5A inhibitor |
Additional relevant MeSH terms:
|
Hepatitis Hepatitis A Hepatitis C Hepatitis, Chronic Hepatitis C, 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 |
ClinicalTrials.gov processed this record on September 23, 2016