Hepatitis CPhase 1NCT01497327
Open-Label Hepatic Impairment Study
A Phase 1 study testing PSI-352938 and PSI-7977 in people with Hepatitis C, run by Gilead Sciences at 2 sites in 2 countries.
Trial summary
This study will be conducted in Hepatitis C positive patients to determine whether the pharmacodynamic effects of PSI-7977 or PSI-352938 are similar to HCV-infected patients with normal hepatic function, which may allow inclusion of patients with cirrhosis and varying degrees of hepatic dysfunction in future clinical… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C
- What is being tested?
- PSI-352938 and PSI-7977
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jul 2011to Jan 2012
- Phase
- Phase 1
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hepatic impaired Males or females of non-childbearing potential aged > 18 years with Chronic HCV-infection
- Naïve to all direct acting anti-viral (DAA) treatments for chronic HCV infection.
- Documented Cirrhosis
Who cannot join
- Prior PEG/RBV null responders.
- Unstable cardiac disease, recent Myocardial infarction, or family history of QTc prolongation or unexplained cardiac arrest.
- Positive test at Screening for anti-HAV IgM Ab, HBsAg, anti-HBc IgM Ab, or anti-human immunodeficiency virus (HIV) Ab.
- History of clinically significant medical condition associated with other chronic liver disease
- Any current signs or symptoms of severe hepatic encephalopathy
- History of gastric or esophageal variceal bleeding in which varices have not been adequately treated with medication and surgical procedures
Show all 12Show fewer
- Prior placement of a portosystemic shunt
- History of hepatorenal, or hepatopulmonary syndrome.
- Active spontaneous bacterial peritonitis.
- Use of medications associated with QT prolongation within 28 days prior to dosing.
- Current Hypotension
- History of Torsades de Pointes, evidence of an active or suspected cancer, or a history of malignancy, Abnormal hematological and biochemical parameters
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: An Open-Label Study to Characterize the Pharmacokinetics and Pharmacodynamics of Multiple Oral Doses of PSI-7977 or PSI-352938 in HCV-infected Subjects With Varying Degrees of Hepatic Impairment
This study will be conducted in Hepatitis C positive patients to determine whether the pharmacodynamic effects of PSI-7977 or PSI-352938 are similar to HCV-infected patients with normal hepatic function, which may allow inclusion of patients with cirrhosis and varying degrees of hepatic dysfunction in future clinical studies.
Read the detailed description
This study is designed per the Food and Drug Administration (FDA) guidance for patients with impaired hepatic function to assess the influence of hepatic impairment on the PK and pharmacodynamics (PD) of PSI-7977 and PSI-352938 This study will be conducted in Hepatitis C positive patients to ascertain whether the PD effects of PSI-7977 or PSI-352938 are similar to HCV-infected patients with normal hepatic function, which may allow inclusion of patients with cirrhosis and varying degrees of hepatic dysfunction in future clinical studies. Data from subjects who participated in the P2938-0212 study (PSI-352938 MAD) will be used as the control group. These subjects were documented non-cirrhotic subjects with normal hepatic function. Hepatitis C Virus (HCV) Genotypes 1-6 will be enrolled in this study.
- Conditions
- Hepatitis C
- Being tested
- PSI-352938, PSI-7977
- Keywords
- HEPATITIS C, CHRONIC, HCV, hepatic impairment
- Medical subject headings
- Hepatitis C, Hepatitis C, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PSI-352938Drug
PSI-352938 300mg once daily (QD) for seven days
PSI-7977Drug
PSI-7977 400mg QD for seven days
| Study group | Role | What they receive |
|---|---|---|
| PSI-352938 Group A | Experimental | Mild (Child-Pugh Class A; 5-6) hepatic impairment Receives: Drug: PSI-352938 |
| PSI-352938 Group B | Experimental | Moderate (Child-Pugh Class B; 7-9) hepatic impairment Receives: Drug: PSI-352938 |
| PSI-352938 Group C | Experimental | Severe (Child-Pugh Class C; 10-15) hepatic impairment Receives: Drug: PSI-352938 |
| PSI-7977 Group A | Experimental | Mild (Child-Pugh Class A; 5-6) hepatic impairment Receives: Drug: PSI-7977 |
| PSI-7977 Group B | Experimental | Moderate (Child-Pugh Class B; 7-9) hepatic impairment Receives: Drug: PSI-7977 |
| PSI-7977 Group C | Experimental | Severe (Child-Pugh Class C; 10-15) hepatic impairment Receives: Drug: PSI-7977 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic data derived from plasma samples collected over 7 days
To characterize the pharmacokinetics (PK) of PSI-352938 over 7 days of dosing with PSI-352938 in HCV-infected patients with varying degrees of hepatic impairment compared to historical PK data.
Measured: 28 time points over Seven Days
Pharmacokinetic comparison with historical data over 7 days of dosing with PSI-7977
To characterize the PK of PSI-7977 and metabolites over 7 days of dosing with PSI-7977 in HCV-infected patients with varying degrees of hepatic impairment compared to historical PK data.
Measured: Seven Days
Secondary outcomes (4)
Number and severity of adverse events
To assess the safety and tolerability of 7 days of dosing of PSI-352938 or PSI-7977 in HCV infected patients with varying degrees of hepatic impairment.
Measured: Seven Days
Viral dynamics/ changes in HCV (ribonucleic acid) RNA
To evaluate the viral dynamics as measured by changes in the HCV RNA in HCV-infected patients with varying degrees of hepatic impairment after 7 days of dosing with PSI-352938 or PSI-7977.
Measured: Baseline through follow-up (post-Day 14)
Changes in genotypic or phenotypic measurements
To assess the presence of baseline polymorphisms in viral isolates and development of viral genotypic and phenotypic changes from baseline.
Measured: Seven Days
Dosage adjustment in hepatically impaired patients
To provide dosage adjustment guidance for PSI-352938 or PSI-7977 based on the degree of hepatic impairment, if applicable.
Measured: Seven days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2011 (estimated)
- Study startJul 2011
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- More trials run by Gilead SciencesThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01497327
- Sponsor's protocol ID
- P2938-0515
- Status last verified
- Jun 2012
- First submitted
- 30 Nov 2011
- Last updated
- 8 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Study to Characterize the Pharmacokinetics and Pharmacodynamics of Multiple Oral Doses of PSI-7977 or PSI-352938 in HCV-infected Subjects With Varying Degrees of Hepatic Impairment
- ClinicalTrials.gov ID
- NCT01497327
- Acronym / sponsor ID
- P2938-0515
- Conditions
- Hepatitis C
- Keywords
- HEPATITIS C, CHRONIC, HCV, hepatic impairment
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- Jul 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 22 Dec 2011 (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 will be conducted in Hepatitis C positive patients to determine whether the pharmacodynamic effects of PSI-7977 or PSI-352938 are similar to HCV-infected patients with normal hepatic function, which may allow inclusion of patients with cirrhosis and varying degrees of hepatic dysfunction in future clinical studies.
Detailed description
This study is designed per the Food and Drug Administration (FDA) guidance for patients with impaired hepatic function to assess the influence of hepatic impairment on the PK and pharmacodynamics (PD) of PSI-7977 and PSI-352938 This study will be conducted in Hepatitis C positive patients to ascertain whether the PD effects of PSI-7977 or PSI-352938 are similar to HCV-infected patients with normal hepatic function, which may allow inclusion of patients with cirrhosis and varying degrees of hepatic dysfunction in future clinical studies. Data from subjects who participated in the P2938-0212 study (PSI-352938 MAD) will be used as the control group. These subjects were documented non-cirrhotic subjects with normal hepatic function. Hepatitis C Virus (HCV) Genotypes 1-6 will be enrolled in this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| PSI-352938 Group A | Experimental | Drug: PSI-352938Mild (Child-Pugh Class A; 5-6) hepatic impairment |
| PSI-352938 Group B | Experimental | Drug: PSI-352938Moderate (Child-Pugh Class B; 7-9) hepatic impairment |
| PSI-352938 Group C | Experimental | Drug: PSI-352938Severe (Child-Pugh Class C; 10-15) hepatic impairment |
| PSI-7977 Group A | Experimental | Drug: PSI-7977Mild (Child-Pugh Class A; 5-6) hepatic impairment |
| PSI-7977 Group B | Experimental | Drug: PSI-7977Moderate (Child-Pugh Class B; 7-9) hepatic impairment |
| PSI-7977 Group C | Experimental | Drug: PSI-7977Severe (Child-Pugh Class C; 10-15) hepatic impairment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Hepatic impaired Males or females of non-childbearing potential aged > 18 years with Chronic HCV-infection
- Naïve to all direct acting anti-viral (DAA) treatments for chronic HCV infection.
- Documented Cirrhosis
Key exclusion criteria (12 listed)
- Prior PEG/RBV null responders.
- Unstable cardiac disease, recent Myocardial infarction, or family history of QTc prolongation or unexplained cardiac arrest.
- Positive test at Screening for anti-HAV IgM Ab, HBsAg, anti-HBc IgM Ab, or anti-human immunodeficiency virus (HIV) Ab.
- History of clinically significant medical condition associated with other chronic liver disease
- Any current signs or symptoms of severe hepatic encephalopathy
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 |
|---|---|---|
| PSI-352938PSI-352938 300mg once daily (QD) for seven days | Drug | PSI-352938 Group A, PSI-352938 Group B, PSI-352938 Group C |
| PSI-7977PSI-7977 400mg QD for seven days | Drug | PSI-7977 Group A, PSI-7977 Group B, PSI-7977 Group C |
Primary outcome
Pharmacokinetic data derived from plasma samples collected over 7 days
Time frame: 28 time points over Seven Days
To characterize the pharmacokinetics (PK) of PSI-352938 over 7 days of dosing with PSI-352938 in HCV-infected patients with varying degrees of hepatic impairment compared to historical PK data.
Pharmacokinetic comparison with historical data over 7 days of dosing with PSI-7977
Time frame: Seven Days
To characterize the PK of PSI-7977 and metabolites over 7 days of dosing with PSI-7977 in HCV-infected patients with varying degrees of hepatic impairment compared to historical PK data.
4 secondary outcomes
Number and severity of adverse events
Time frame: Seven Days
Viral dynamics/ changes in HCV (ribonucleic acid) RNA
Time frame: Baseline through follow-up (post-Day 14)
Changes in genotypic or phenotypic measurements
Time frame: Seven Days
Dosage adjustment in hepatically impaired patients
Time frame: Seven days
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 8 Jun 2012.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PSI-352938 and PSI-7977 in people with Hepatitis C, run by Gilead Sciences at 2 sites in 2 countries.
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 3 inclusion and 12 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 8 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Puerto Rico. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Pharmacokinetic data derived from plasma samples collected over 7 days (time frame: 28 time points over Seven Days). The study lists 2 primary outcomes in all. 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 8 Jun 2012; AzTrials last refreshed its copy on 28 Oct 2026.