Hepatitis C InfectionPhase 2NCT01265511
Study of SCY-635, Pegasys and Copegus in Hepatitis C
A Phase 2 study testing SCY-635, Pegasys and Copegus in people with Hepatitis C Infection, run by Scynexis, Inc. at 4 sites in 2 countries.
Trial summary
This study will examine the effectiveness of 28 days of triple combination therapy including SCY-635 with peginterferon alfa 2a and ribavirin in reducing serum HCV RNA levels. An additional 20 weeks of treatment with the currently approved standard of care will be offered to all participants. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hepatitis C Infection
- What is being tested?
- SCY-635, Pegasys and Copegus
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Nov 2010to Oct 2011
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Quantifiable serum levels of HCV-specific RNA in excess of 100,000 IU/mL
- Chronic HCV status
- HCV genotype 1 infection and IL28B genotype of C/T or T/T
- Liver biopsy results within 3 years prior to screening indicating the absence of cirrhosis
- If no previous biopsy is available, a biopsy must be performed during the screening period to qualify for randomization
- Body mass index (BMI) between 18 and 38 kg/m2
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- Laboratory variables within acceptable ranges:
- ALT/AST < 3 × ULN;
- HgB > 12g/dL for females, > 13 g/dL for males;
- total WBC count > 3000/mm3 and ANC > 1500/mm3;
- platelets > 100,000/mm3;
- prothrombin time (or INR) ≤ 1.2 × ULN;
- serum albumin ≥ 3.4 g/dL;
- total bilirubin WNL;
- serum creatinine WNL; if serum creatinine is > ULN, then calculated creatinine clearance must be > 100 mL/min (by Cockcroft-Gault formula) for subject to be eligible
- Subjects of childbearing potential (i.e., not surgically sterile or postmenopausal) must agree to use 2 forms of contraception from Screening until 24 weeks after completion of treatment with RBV
- Negative urine testing for amphetamines and cocaine at Screening.
- If female, the subject has a negative pregnancy test at Screening and on study Day 1
Who cannot join
- History of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, psychiatric, or cardiovascular disease
- Females who are pregnant or breastfeeding
- Males with partners who are pregnant or are planning to become pregnant
- HCV genotype other than genotype 1 and an IL28B genotype of C/C
- Seropositive for HIV-1 or HIV-2 or hepatitis B virus (HBV) surface antigen (HBsAg)
- Use of any investigational agent within 3 months prior to dosing
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- Received any prior FDA-approved or investigational drug or drug regimen for the treatment of hepatitis C
- Evidence of cirrhosis on a previous liver biopsy
- Evidence of decompensated liver disease
- Recipient of an organ transplant
- Evidence of hepatocellular carcinoma
- Evidence of ongoing alcohol or substance abuse
- Poorly-controlled diabetes mellitus
- Congestive heart failure or unstable cardiopulmonary condition, renal disease, or hemoglobinopathy (sickle cell anemia or thalassemia
- History of seizure disorder
- History of severe psychiatric illness, including severe depression, history of suicidal ideation, suicidal attempts, related hospitalizations, bipolar disorder, or psychosis requiring medication
- Concurrent medical condition or laboratory abnormality that would constitute a contra-indication for interferon use
- History of unstable thyroid disease that would preclude administration of interferon-based therapy
- Medical condition that requires use of systemic corticosteroids
- Received warfarin or other anticoagulants during the 21 days immediately prior to Screening, or is expected to require warfarin or other anticoagulants during the study.
- One or more additional known primary or secondary causes of liver disease, other than hepatitis C
- Any other concurrent medical condition likely to preclude compliance with the schedule of evaluations, or likely to confound the efficacy or safety observations
- 12-lead ECG showing the following:
- Corrected QTc interval ≥ 450 msec (Bazett's correction);
- QRS > 120 msec;
- Clinically significant abnormalities;
- Severe retinopathy or other significant ophthalmological disorder
- Use of any herbal supplements within 28 days prior to dosing.
- The use of CYP3A inducers or inhibitors for at least 2 weeks prior to initiation of treatment through Week 6
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United States3 sites
Duke University Medical Center
Durham, North Carolina, 27710
Alamo Medical Research
San Antonio, Texas, 78215
Quest Clinical Research
San Francisco, California, 94115
About this study
Official title: A Phase 2a Study of SCY-635 in Combination With Peginterferon Alfa-2a (Pegasys) and Ribavirin (Copegus) in Treatment-Naive Subjects With Genotype 1 Hepatitis C Infection
This study will examine the effectiveness of 28 days of triple combination therapy including SCY-635 with peginterferon alfa 2a and ribavirin in reducing serum HCV RNA levels. An additional 20 weeks of treatment with the currently approved standard of care will be offered to all participants. The Week 24 visit will be the last on-study visit. After the Week 24 visit, all subjects with undetectable HCV RNA will be given the option to continue treatment with standard of care for an additional 24 weeks (out to Week 48) under the care of their Principal Investigator.
Read the detailed description
Objectives:
The primary objective of this Phase 2a study was to assess the effect of treatment with SCY-635, used in combination with peginterferon alfa-2a (PegIFN α-2a) and ribavirin (RBV), on hepatitis C viral replication (as measured by quantitative serum HCV RNA) in treatment-naive subjects with chronic genotype 1 infection who have an IL28B genotype of C/T or T/T.
The secondary objective of the study was to evaluate the safety and pharmacokinetics (PK) of SCY-635 when given in combination with PegIFN α-2a and RBV.
Primary Endpoints:
Proportion of subjects in each cohort with an undetectable serum HCV RNA level at Week 4 of treatment
Secondary Endpoints:
Adverse events and clinical laboratory assessments, including tests of liver function Proportion of subjects achieving complete early virologic response (cEVR, defined as an undetectable serum HCV RNA level at Week 12) Proportion of subjects achieving partial early virologic response (pEVR, defined as a detectable serum HCV RNA level with ≥ 2 log10 reduction in serum HCV RNA from Baseline to Week 12) Proportion of subjects achieving an undetectable serum HCV RNA level at Week 24 Pharmacokinetic assessments of SCY-635 when given in combination with PegIFN α-2a and RBV; trough concentrations of PegIFN α-2a and RB
- Conditions
- Hepatitis C Infection
- Being tested
- Placebo, SCY-635, Pegasys, Copegus
- Keywords
- Hepatitis C, SCY-635, Ribavirin, Interferon
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Also called Batch # BMR/10/731
Oral tablets given bid for 28 days
SCY-635Drug
SCY-635 tablets, 300 mg bid for 28 days
PegasysDrug
180 ug prefilled syringe given once per week for up to 48 weeks
CopegusDrug
tablets given bid for up to 48 weeks
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo + PegIFN + RBV for 4 weeks followed by PegIFN + RBV for 20 weeks Receives: Drug: Placebo; Drug: Pegasys; Drug: Copegus |
| SCY-635 600 mg | Active comparator | SCY-635 600 mg + PegIFN + RBV for 4 weeks followed by PegIFN + RBV for 20 weeks Receives: Drug: SCY-635; Drug: Pegasys; Drug: Copegus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Undetectable HCV RNA
Measured: Week 4
Secondary outcomes (3)
Undetectable HCV RNA
Measured: Week 12
Partial Early Virologic Response
Proportion of subjects with detectable HCV RNA that achieve a > or = 2 log reduction in HCV RNA from baseline to Week 12
Measured: Week 12
Undetectable HCV RNA
Measured: Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2010 (estimated)
- Study startNov 2010
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hepatitis C InfectionStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Scynexis, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andrew J Muir, MD, Principal investigator, Duke Clinical Research InstituteKeyur Patel, MD, Principal investigator, Duke Clinical Ressearch Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01265511
- Sponsor's protocol ID
- SCY-635-201
- Status last verified
- Jul 2017
- First submitted
- 23 Nov 2010
- Last updated
- 18 Aug 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a Study of SCY-635 in Combination With Peginterferon Alfa-2a (Pegasys) and Ribavirin (Copegus) in Treatment-Naive Subjects With Genotype 1 Hepatitis C Infection
- ClinicalTrials.gov ID
- NCT01265511
- Acronym / sponsor ID
- SCY-635-201
- Conditions
- Hepatitis C Infection
- Keywords
- Hepatitis C, SCY-635, Ribavirin, Interferon
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Scynexis, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2010
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 23 Dec 2010 (estimated)
- Results
- Posted 18 Aug 2017
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 examine the effectiveness of 28 days of triple combination therapy including SCY-635 with peginterferon alfa 2a and ribavirin in reducing serum HCV RNA levels. An additional 20 weeks of treatment with the currently approved standard of care will be offered to all participants. The Week 24 visit will be the last on-study visit. After the Week 24 visit, all subjects with undetectable HCV RNA will be given the option to continue treatment with standard of care for an additional 24 weeks (out to Week 48) under the care of their Principal Investigator.
Detailed description
Objectives:
The primary objective of this Phase 2a study was to assess the effect of treatment with SCY-635, used in combination with peginterferon alfa-2a (PegIFN α-2a) and ribavirin (RBV), on hepatitis C viral replication (as measured by quantitative serum HCV RNA) in treatment-naive subjects with chronic genotype 1 infection who have an IL28B genotype of C/T or T/T.
The secondary objective of the study was to evaluate the safety and pharmacokinetics (PK) of SCY-635 when given in combination with PegIFN α-2a and RBV.
Primary Endpoints:
Proportion of subjects in each cohort with an undetectable serum HCV RNA level at Week 4 of treatment
Secondary Endpoints:
Adverse events and clinical laboratory assessments, including tests of liver function Proportion of subjects achieving complete early virologic response (cEVR, defined as an undetectable serum HCV RNA level at Week 12) Proportion of subjects achieving partial early virologic response (pEVR, defined as a detectable serum HCV RNA level with ≥ 2 log10 reduction in serum HCV RNA from Baseline to Week 12) Proportion of subjects achieving an undetectable serum HCV RNA level at Week 24 Pharmacokinetic assessments of SCY-635 when given in combination with PegIFN α-2a and RBV; trough concentrations of PegIFN α-2a and RB
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo, Drug: Pegasys, Drug: CopegusPlacebo + PegIFN + RBV for 4 weeks followed by PegIFN + RBV for 20 weeks |
| SCY-635 600 mg | Active comparator | Drug: SCY-635, Drug: Pegasys, Drug: CopegusSCY-635 600 mg + PegIFN + RBV for 4 weeks followed by PegIFN + RBV for 20 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Quantifiable serum levels of HCV-specific RNA in excess of 100,000 IU/mL
- Chronic HCV status
- HCV genotype 1 infection and IL28B genotype of C/T or T/T
- Liver biopsy results within 3 years prior to screening indicating the absence of cirrhosis
- If no previous biopsy is available, a biopsy must be performed during the screening period to qualify for randomization
Key exclusion criteria (29 listed)
- History of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, psychiatric, or cardiovascular disease
- Females who are pregnant or breastfeeding
- Males with partners who are pregnant or are planning to become pregnant
- HCV genotype other than genotype 1 and an IL28B genotype of C/C
- Seropositive for HIV-1 or HIV-2 or hepatitis B virus (HBV) surface antigen (HBsAg)
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 |
|---|---|---|
| PlaceboAlso: Batch # BMR/10/731Oral tablets given bid for 28 days | Drug | Placebo |
| SCY-635SCY-635 tablets, 300 mg bid for 28 days | Drug | SCY-635 600 mg |
| Pegasys180 ug prefilled syringe given once per week for up to 48 weeks | Drug | Placebo, SCY-635 600 mg |
| Copegustablets given bid for up to 48 weeks | Drug | Placebo, SCY-635 600 mg |
Primary outcome
Undetectable HCV RNA
Time frame: Week 4
3 secondary outcomes
Undetectable HCV RNA
Time frame: Week 12
Partial Early Virologic Response
Time frame: Week 12
Undetectable HCV RNA
Time frame: Week 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Andrew J Muir, MD principal investigator
Duke Clinical Research Institute
Keyur Patel, MD principal investigator
Duke Clinical Ressearch Institute
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SCY-635, Pegasys and Copegus in people with Hepatitis C Infection, run by Scynexis, Inc. at 4 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 18 inclusion and 29 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 18 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 18 Aug 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Undetectable HCV RNA (time frame: Week 4). 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 18 Aug 2017; AzTrials last refreshed its copy on 7 Nov 2026.