Chronic Hepatitis CPhase 2NCT01859962
Study of PPI-668, BI 207127 and Faldaprevir, With and Without Ribavirin, in the Treatment of Chronic Hepatitis C
A Phase 2 study testing PPI-668, BI 207127 Dose 1 and BI 207127 Dose 2 in people with Chronic Hepatitis C, run by Presidio Pharmaceuticals, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Hepatitis C
- What is being tested?
- PPI-668, BI 207127 Dose 1 and BI 207127 Dose 2
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- May 2013to Dec 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Quest Clinical Research
San Francisco, California, 94115
About this study
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)
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.
- Conditions
- Chronic Hepatitis C
- Being tested
- PPI-668, BI 207127 Dose 1, BI 207127 Dose 2, Faldaprevir, Ribavirin
- Keywords
- Liver diseases, Virus diseases, Ribavirin, protease inhibitor, NS5B polymerase inhibitor, NS5A inhibitor
- Medical subject headings
- Hepatitis C, Chronic, Liver Diseases, Virus Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PPI-668Drug
BI 207127 Dose 1Drug
BI 207127 Dose 2Drug
FaldaprevirDrug
RibavirinDrug
BI 207127 PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| PPI-668, BI 207127 Dose 1, Faldaprevir, and Ribavirin | Active comparator | PPI-668, BI 207127 Dose 1, Faldaprevir, and Ribavirin dosed in combination Receives: Drug: PPI-668; Drug: BI 207127 Dose 1; Drug: Faldaprevir; Drug: Ribavirin |
| PPI-668, BI 207127 Dose 2, Faldaprevir, and Ribavirin | Active comparator | PPI-668, BI 207127 Dose 2, BI 207127 Placebo, Faldaprevir, and Ribavirin dosed in combination Receives: Drug: PPI-668; Drug: BI 207127 Dose 2; Drug: Faldaprevir; Drug: Ribavirin; Drug: BI 207127 Placebo |
| PPI-668, BI 207127 Dose 1, and Faldaprevir | Active comparator | PPI-668, BI 207127 Dose 1, and Faldaprevir dosed in combination Receives: Drug: PPI-668; Drug: BI 207127 Dose 1; Drug: Faldaprevir |
What is being measured
The primary outcome is the main question the study is designed to answer.
the proportion of patients achieving sustained viral response (SVR)
Measured: 12 weeks after the end of treatment
Secondary outcomes (4)
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
Measured: up to 24 weeks post-treatment
Proportion of patients with confirmed viral breakthrough during 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
Measured: up to 12 weeks of study treatment
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
Measured: 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
Measured: up to 12 weeks of study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2013 (estimated)
- Study startMay 2013
- Primary completionMay 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis CStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Presidio Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Boehringer Ingelheim
- Responsible party
- Sponsor
- Investigators
- Nathaniel Brown, MD, Study director, Presidio Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01859962
- Sponsor's protocol ID
- PPI-668-201
- Status last verified
- Nov 2015
- First submitted
- 17 May 2013
- Last updated
- 25 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01859962
- Acronym / sponsor ID
- PPI-668-201
- Conditions
- Chronic Hepatitis C
- Keywords
- Liver diseases, Virus diseases, Ribavirin, protease inhibitor, NS5B polymerase inhibitor, NS5A inhibitor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Presidio Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Boehringer Ingelheim
- Study start
- May 2013
- Primary completion
- May 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 22 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PPI-668, BI 207127 Dose 1, Faldaprevir, and Ribavirin | Active comparator | Drug: PPI-668, Drug: BI 207127 Dose 1, Drug: Faldaprevir, Drug: RibavirinPPI-668, BI 207127 Dose 1, Faldaprevir, and Ribavirin dosed in combination |
| PPI-668, BI 207127 Dose 2, Faldaprevir, and Ribavirin | Active comparator | Drug: PPI-668, Drug: BI 207127 Dose 2, Drug: Faldaprevir, Drug: Ribavirin, Drug: BI 207127 PlaceboPPI-668, BI 207127 Dose 2, BI 207127 Placebo, Faldaprevir, and Ribavirin dosed in combination |
| PPI-668, BI 207127 Dose 1, and Faldaprevir | Active comparator | Drug: PPI-668, Drug: BI 207127 Dose 1, Drug: FaldaprevirPPI-668, BI 207127 Dose 1, and Faldaprevir dosed in combination |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PPI-668 | Drug | PPI-668, BI 207127 Dose 1, Faldaprevir, and Ribavirin, PPI-668, BI 207127 Dose 1, and Faldaprevir, PPI-668, BI 207127 Dose 2, Faldaprevir, and Ribavirin |
| BI 207127 Dose 1 | Drug | PPI-668, BI 207127 Dose 1, Faldaprevir, and Ribavirin, PPI-668, BI 207127 Dose 1, and Faldaprevir |
| BI 207127 Dose 2 | Drug | PPI-668, BI 207127 Dose 2, Faldaprevir, and Ribavirin |
| Faldaprevir | Drug | PPI-668, BI 207127 Dose 1, Faldaprevir, and Ribavirin, PPI-668, BI 207127 Dose 1, and Faldaprevir, PPI-668, BI 207127 Dose 2, Faldaprevir, and Ribavirin |
| Ribavirin | Drug | PPI-668, BI 207127 Dose 1, Faldaprevir, and Ribavirin, PPI-668, BI 207127 Dose 2, Faldaprevir, and Ribavirin |
| BI 207127 Placebo | Drug | PPI-668, BI 207127 Dose 2, Faldaprevir, and Ribavirin |
Primary outcome
the proportion of patients achieving sustained viral response (SVR)
Time frame: 12 weeks after the end of treatment
4 secondary outcomes
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nathaniel Brown, MD study director
Presidio Pharmaceuticals, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PPI-668, BI 207127 Dose 1 and BI 207127 Dose 2 in people with Chronic Hepatitis C, run by Presidio Pharmaceuticals, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the proportion of patients achieving sustained viral response (SVR) (time frame: 12 weeks after the end of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2015.