Study of CTS-1027 in Combination With Pegylated Interferon and Ribavirin in Hepatitis C Virus (HCV) Null-Responders

NCT01051921 | Completed Phase 2 Results DMC

• 1 other identifier: CTS-1027-04
• Study Type: interventional
• Target: 67
• Locations: 2 countries
• Sites: 15

Brief Summary

The purpose of this study is to determine if the combination treatment of CTS-1027, pegylated interferon and ribavirin can improve the response rates in HCV patients who did not previously respond to pegylated interferon and ribavirin therapy.

Conditions

Hepatitis C

Keywords

HCV; Null Responder

Outcome Measures

Primary Outcomes (1)

• Early Virologic Response (EVR)

  Early Virologic Response (EVR) is defined as the percent of patients who experienced a drop in HCV-RNA (Hepatitis C Ribonucleic acid, also known as "viral load") levels of more that 2 log from before treatment (baseline) through 12 Weeks of treatment.

  Baseline and Study week 12

Secondary Outcomes (1)

• > 2 Log Decline in Hepatitis C Virus Ribonucleic Acid (HCV-RNA) at 24 Weeks

  Baseline and Study week 24

Study Arms (1)

CTS-1027, Peg IFN, Ribavirin

EXPERIMENTAL

Study drug (CTS-1027) plus Standard of Care treatment (pegylated interferon and ribavirin). CTS-1027, 15 mg taken twice daily. Pegylated interferon, 180 μg injected once a week. Ribavirin, 1000 mg or 1200 mg daily (depending on patient weight), taken in two divided doses.

Drug: CTS-1027; Drug: Pegylated interferon; Drug: Ribavirin

Interventions

CTS-1027 DRUG

CTS-1027 supplied in 5 and 10 mg tablets, 15 mg taken twice daily, for up to 48 weeks

CTS-1027, Peg IFN, Ribavirin

Pegylated interferon DRUG

Pegylated interferon, 180 micrograms in 0.5 ml of solution injected subcutaneously (SQ) once per week, for up to 48 weeks. Packaged in single use syringes.

Also known as: Pegasys

CTS-1027, Peg IFN, Ribavirin

Ribavirin DRUG

Ribavirin, 200 mg capsules taken in two divided daily doses totaling 1000 mg (5 capsules) for patients weighing 75 kg or less, or 1200 mg (6 capsules) for patients weighing more than 75 kg for up to 48 weeks.

Also known as: Copegus

CTS-1027, Peg IFN, Ribavirin

Eligibility Criteria

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

You may qualify if:

• Male or female patients of minimum adult legal age (according to local laws for signing the informed consent document), able to provide written informed consent, and understand and comply with the requirements of the trial
• HCV genotype 1 infected null responders to prior therapy comprised of pegylated interferon and ribavirin (standard of care, SOC) defined as:
• Failure to achieve an early virologic response (\< 2 log decline in HCV-RNA by Week 12), or
• If Week 12 HCV-RNA was not obtained but Week 24 was obtained, Week 24 response was \< 2 log decline
• Alpha-fetoprotein (AFP) \<= 50 ng/mL
• Hemoglobin ≥ 12 g/dL, platelet count ≥ 125 x 10\^9/L, and white blood cell count ≥ 1.5 x 10\^9/L
• In the opinion of the Principal Investigator, the patient met the 80%/80%/80% rule during the previous pegylated interferon and ribavirin therapy (i.e., received at least 80% of the pegylated interferon and ribavirin doses, at least 80% of the dose size, for at least 80% of the treatment duration)
• Willingness to utilize two reliable forms of contraception (for both males and females of childbearing potential) from screening to at least six months after the completion of the trial.

You may not qualify if:

• \< 2 log decline in HCV-RNA at Week 12 but \> 2 log decline at any time from Week 12 to Week 24 during prior therapy with pegylated interferon and ribavirin (prior standard of care therapy)
• Decompensated or severe liver disease defined by one or more of the following criteria:
• Prothrombin time 3 seconds \> control
• Direct bilirubin ≥ 1.5 x ULN
• Serum albumin below normal limits
• AST or ALT \> 7 x ULN at screening
• Evidence of portal hypertension including:
• Varices on esophagogastroduodenoscopy (EGD) with or without a history of gastrointestinal bleeding; or
• Ascites
• Cirrhosis defined by one or both of the following criteria:
• Liver biopsy showing cirrhosis
• Other clinical signs and symptoms suggestive of cirrhosis
• Hepatocellular carcinoma (HCC) or suspicion of HCC clinically or on ultrasound (or other imaging techniques)
• Clinically significant ocular findings such as retinopathy, cotton wool spots, optic nerve disorder, retinal hemorrhage, or other abnormality
• Known history or presence of human immunodeficiency virus (HIV) infection

Sponsors & Collaborators

• Conatus Pharmaceuticals Inc.: lead

Study Sites (15)

Scripps Clinic

La Jolla, California, 92037, United States

Location

VA Medical Center, San Diego

San Diego, California, 92161, United States

Location

University of Colorado Health Science Center

Denver, Colorado, 80262, United States

Location

South Denver Gastroenterology

Englewood, Colorado, 80113, United States

Location

Digestive Healthcare of Georgia

Atlanta, Georgia, 30309, United States

Location

Tulane University Health Sciences Center

New Orleans, Louisiana, 70112, United States

Location

Henry Ford Medical Center-Columbus

Novi, Michigan, 48377, United States

Location

MN Clinical Research Center

Plymouth, Minnesota, 55446, United States

Location

St. Louis University

St Louis, Missouri, 63104, United States

Location

Consultants of Clinical Research, Ohio GI and Liver Institute

Cincinnati, Ohio, 45219, United States

Location

Advanced Liver Therapies - Baylor College of Medicine

Houston, Texas, 77030, United States

Location

VA Medical Center, Houston

Houston, Texas, 77030, United States

Location

University of Utah Health Science Center

Salt Lake City, Utah, 84132, United States

Location

Liver Institute of Virginia

Newport News, Virginia, 23602, United States

Location

Fundacion de Investigacion de Diego

Santurce, 00909, Puerto Rico

Location

MeSH Terms

Conditions

Hepatitis C

Interventions

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

Limitations and Caveats

Although this study was completed, the entire CTS-1027 program was discontinued prior to database lock. Hence, only a safety analysis was carried out for this study. Analysis of the primary and secondary efficacy measures was not completed.

Results Point of Contact

• Title: Vice President, Clinical Development
• Organization: Conatus Pharmaceuticals Inc.

MHuyghe@conatuspharma.com

(858) 457- 7227

Study Officials

• Erin Castelloe, MD

  Conatus Pharmaceuticals Inc.

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2010
• First Posted: January 20, 2010
• Study Start: January 1, 2010
• Primary Completion: November 1, 2011
• Study Completion: December 1, 2011
• Last Updated: April 16, 2012
• Results First Posted: April 10, 2012

Record last verified: 2012-04

Locations

US (14); PR (1)