Study of PPI-668, BI 207127 and Faldaprevir, With and Without Ribavirin, in the Treatment of Chronic Hepatitis C
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ClinicalTrials.gov Identifier: NCT01859962 |
Recruitment Status :
Completed
First Posted : May 22, 2013
Last Update Posted : November 25, 2015
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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 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 |

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
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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 |
- the proportion of patients achieving sustained viral response (SVR) [ Time Frame: 12 weeks after the end of treatment ]
- 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 ]

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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

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
United States, California | |
Quest Clinical Research | |
San Francisco, California, United States, 94115 |
Study Director: | Nathaniel Brown, MD | Presidio Pharmaceuticals, Inc. |
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 |
Liver diseases Virus diseases Ribavirin |
protease inhibitor NS5B polymerase inhibitor NS5A inhibitor |
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 |