Study of SCY-635, Pegasys and Copegus in Hepatitis C

NCT01265511 | Completed Phase 2 Results

• 1 other identifier: SCY-635-201
• Study Type: interventional
• Target: 10
• Locations: 2 countries
• Sites: 4

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 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.

Conditions

Hepatitis C Infection

Keywords

Hepatitis C; SCY-635; Ribavirin; Interferon

Outcome Measures

Primary Outcomes (1)

• Undetectable HCV RNA

  Week 4

Secondary Outcomes (3)

• Undetectable HCV RNA

  Week 12

• Partial Early Virologic Response

  Week 12

• Undetectable HCV RNA

  Week 24

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo + PegIFN + RBV for 4 weeks followed by PegIFN + RBV for 20 weeks

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

Drug: SCY-635; Drug: Pegasys; Drug: Copegus

Interventions

Placebo DRUG

Oral tablets given bid for 28 days

Also known as: Batch # BMR/10/731

Placebo

SCY-635 DRUG

SCY-635 tablets, 300 mg bid for 28 days

SCY-635 600 mg

Pegasys DRUG

180 ug prefilled syringe given once per week for up to 48 weeks

Placebo; SCY-635 600 mg

Copegus DRUG

tablets given bid for up to 48 weeks

Placebo; SCY-635 600 mg

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Scynexis, Inc.: lead

Study Sites (4)

Quest Clinical Research

San Francisco, California, 94115, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Alamo Medical Research

San Antonio, Texas, 78215, United States

Location

Fundacion de Investigation de Diego

San Juan, 00927, Puerto Rico

Location

MeSH Terms

Conditions

Hepatitis C

Interventions

SCY-635; peginterferon alfa-2a; Ribavirin

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Results Point of Contact

• Title: Katyna Borroto-Esoda
• Organization: Scynexis

katyna.borroto-esoda@scynexis.com

9192374431

Study Officials

• Andrew J Muir, MD

  Duke Clinical Research Institute

  PRINCIPAL INVESTIGATOR

• Keyur Patel, MD

  Duke Clinical Ressearch Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2010
• First Posted: December 23, 2010
• Study Start: November 1, 2010
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: August 18, 2017
• Results First Posted: August 18, 2017

Record last verified: 2017-07

Locations

US (3); PR (1)