Study of Nitazoxanide, Peginterferon Alfa-2a and Ribavirin in Treatment-Naive Hepatitis C Patients

NCT00637923 | Completed Phase 2 Results DMC

• 1 other identifier: RM01-2026
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 10

Brief Summary

The purpose of this study is to determine if nitazoxanide in combination with peginterferon alfa-2a and ribavirin is safe and effective in treating chronic hepatitis C in treatment-naive patients.

Conditions

Chronic Hepatitis C

Keywords

Hepatitis C, Chronic

Outcome Measures

Primary Outcomes (1)

• Sustained Virologic Response (HCV RNA Below Lower Limit of Detection)

  Hepatitis C Virus Ribonucleic Acid (HCV RNA) below lower limit of detection 24 weeks after the end of treatment. All others were considered non-responders.

  24 weeks after end of treatment

Secondary Outcomes (7)

• End of Treatment Response (HCV RNA Below Lower Limit of Detection)

  At end of treatment

• Early Virologic Response (HCV RNA Below Lower Limit of Detection)

  After 12 weeks combination treatment

• Rapid Virologic Response (HCV RNA Below Lower Limit of Detection)

  After 4 weeks combination treatment

• Changes in ALT

  From baseline to week 8

• Changes in ALT

  From baseline to week 16

Study Arms (2)

1

EXPERIMENTAL

One nitazoxanide 500 mg tablet orally with food twice daily (b.i.d.) for 4 weeks followed by 500 mg nitazoxanide b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.

Drug: Nitazoxanide; Biological: Peginterferon alfa-2a; Drug: Ribavirin

2

PLACEBO COMPARATOR

One placebo tablet orally with food twice daily (b.i.d.) for 4 weeks followed by placebo b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.

Drug: Placebo; Biological: Peginterferon alfa-2a; Drug: Ribavirin

Interventions

Nitazoxanide DRUG

One nitazoxanide 500 mg tablet orally with food twice daily (b.i.d.) for 4 weeks followed by 500 mg nitazoxanide b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.

Also known as: Alinia

1

Placebo DRUG

One placebo tablet orally with food twice daily (b.i.d.) for 4 weeks followed by placebo b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.

2

Peginterferon alfa-2a BIOLOGICAL

One weekly injection of 180µg of peginterferon α-2a for 48 weeks.

Also known as: PEGASYS

1; 2

Ribavirin DRUG

Weight-based ribavirin for 48 weeks.

Also known as: COPEGUS

1; 2

Eligibility Criteria

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

You may qualify if:

• Chronic hepatitis C genotype 1.

You may not qualify if:

• Patients that have previously received treatment with any interferon or interferon-based treatment for chronic hepatitis C.
• Females of child-bearing age who are either pregnant, breast-feeding or not using birth control and are sexually active.
• Males whose female partners are either pregnant or of child-bearing potential or not using birth control and are sexually active.
• Other causes of liver disease including autoimmune hepatitis.
• Transplant recipients receiving immune suppression therapy.
• Screening tests positive for Anti-Hepatitis A Virus Immunoglobulin M Antibody (anti-HAV IgM Ab), Hepatitis B's antigen (HBsAg), Anti-Hepatitis B core Immunoglobulin M Antibody (anti-HBc IgM Ab) or Anti-Human Immunodeficiency Virus Antibody (anti-HIV Ab).
• Decompensated cirrhosis, history of variceal bleeding, ascites, hepatic encephalopathy, Child-Turcotte-Pugh (CTP) score \>6 or Model for End-stage Liver Disease (MELD) score \>8.
• Alcohol consumption of \>40 grams per day or an alcohol use pattern that will interfere with the study.
• Absolute neutrophil count \<1500 cells/mm3; platelet count \<135,000 cells/mm3; hemoglobin \<12 g/dL for women and \<13 g/dL for men; or serum creatinine concentration ≥1.5 times Upper Limit of Normal (ULN).
• Hypothyroidism or hyperthyroidism not effectively treated with medication.
• Hemoglobin A1C (HgbA1c) \>7.5 or history of diabetes mellitus.
• Body Mass Index (BMI) \>34.
• History or other clinical evidence of significant or unstable cardiac disease.
• History or other clinical evidence of chronic pulmonary disease associated with functional impairment.
• Serious or severe bacterial infection(s).

Sponsors & Collaborators

• Romark Laboratories L.C.: lead

Study Sites (10)

Palo Alto VA Healthcare System

Palo Alto, California, 94304, United States

Location

Yale University School of Medicine

New Haven, Connecticut, 06520, United States

Location

Bay Pines VA Healthcare System

Bay Pines, Florida, 33744, United States

Location

Florida Center for Gastroenterology

Largo, Florida, 33777, United States

Location

Atlanta Gastroenterology Associates

Atlanta, Georgia, 30308, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

New York Presbyterian-Weill Medical College of Cornell University

New York, New York, 10021, United States

Location

Nashville Medical Research Institute

Nashville, Tennessee, 37205, United States

Location

Metropolitan Research

Fairfax, Virginia, 22031, United States

Location

MeSH Terms

Conditions

Hepatitis C, Chronic

Interventions

nitazoxanide; peginterferon alfa-2a; Ribavirin

Condition Hierarchy (Ancestors)

Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Results Point of Contact

• Title: Marc Ayers
• Organization: Romark Laboratories, L.C.

Marc.Ayers@romark.com

813-282-8544

Study Officials

• Emmet B Keeffe, MD, MACP

  Romark Laboratories L.C.

  STUDY DIRECTOR

• Norman Gitlin, MD

  Atlanta Gastroenterology Associates

  PRINCIPAL INVESTIGATOR

• Joseph K Lim, MD

  Yale University

  PRINCIPAL INVESTIGATOR

• Ira Jacobson, MD

  New York Presbyterial-Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

• Mitchell L Shiffman, MD

  McGuire Veteran's Administration Medical Center

  PRINCIPAL INVESTIGATOR

• Ronald E Pruitt, MD

  Nashville Medical Research Institute

  PRINCIPAL INVESTIGATOR

• Arthur Berman, DO

  Florida Center for Gastroenterology

  PRINCIPAL INVESTIGATOR

• Bruce Bacon, MD

  St. Louis University Medical Center

  PRINCIPAL INVESTIGATOR

• Nezam Afdhal, MD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

• David Johnson, MD

  Bay Pines VA Healthcare System

  PRINCIPAL INVESTIGATOR

• Raymond Chung, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

• Vinod Rustgi, MD

  Metropolitan Research

  PRINCIPAL INVESTIGATOR

• Aijaz Ahmed, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

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: March 11, 2008
• First Posted: March 18, 2008
• Study Start: March 1, 2008
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2010
• Last Updated: February 10, 2014
• Results First Posted: January 6, 2014

Record last verified: 2014-01

Locations

US (10)