Status:
COMPLETED
Study of SCY-635, Pegasys and Copegus in Hepatitis C
Lead Sponsor:
Scynexis, Inc.
Conditions:
Hepatitis C Infection
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief 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 o...
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 hepat...
Eligibility Criteria
Inclusion
- 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
- 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
Exclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01265511
Start Date
November 1 2010
End Date
October 1 2011
Last Update
August 18 2017
Active Locations (4)
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1
Quest Clinical Research
San Francisco, California, United States, 94115
2
Duke University Medical Center
Durham, North Carolina, United States, 27710
3
Alamo Medical Research
San Antonio, Texas, United States, 78215
4
Fundacion de Investigation de Diego
San Juan, Puerto Rico, 00927