Safety and Tolerability Study of Clemizole Hydrochloride to Treat Hepatitis C in Subjects Who Are Treatment-Naive

NCT00945880 | Completed Phase 1

• 1 other identifier: EIG-101
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to test the hypothesis that clemizole hydrochloride is safe and well tolerated when administered to subjects who are infected with hepatitis C virus and have not yet received treatment. This study will also examine how the virus and body respond to clemizole hydrochloride.

Conditions

Hepatitis C

Keywords

HCV; Hepatitis C; Hepatitis

Outcome Measures

Primary Outcomes (1)

• Evaluate the pharmacodynamic (PD) activity of a 100 mg po BID dose of clemizole hydrochloride on HCV viral load

  Day 1, 3, 7, 14, 28, 56

Secondary Outcomes (2)

• Evaluate the pharmacokinetics (PK) of a 100 mg po BID dose of clemizole hydrochloride in subjects chronically infected with HCV

  Day 1 and Day 28

• Evaluate the safety and tolerability of four weeks of treatment with a 100 mg po BID dose of clemizole hydrochloride through review of adverse events

  Day 1, 2, 3, 7, 14, 28, 56

Study Arms (1)

Experimental Group

EXPERIMENTAL

clemizole hydrochloride, 100mg, BID

Drug: clemizole hydrochloride

Interventions

clemizole hydrochloride DRUG

Two 50 mg capsules containing clemizole hydrochloride are to be administered orally twice a day for 28 days for a total daily dose of 200 mg. Followed immediately by standard of care treatment consisting of interferon and ribavirin

Experimental Group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Males or females, 18 to 55 years of age who are diagnosed with HCV by PCR
• HCV treatment-naïve patients who have already committed to undergo standard of care therapy (SOC) for HCV (pegylated interferon and ribavirin), and who wish to participate in a study immediately prior to the initiation of SOC
• Chronic hepatitis C infection, genotype 1 or genotype 2, two documented tests (PCR or HCV Ab; if one of the tests is HCV Ab, then the second test must be PCR and the PCR test must be at least 6 months after the HCV Ab test) at least 6 months apart
• Liver biopsy within the last two (2) years (biopsy can be done at the Screening Visit)
• Positive viral load of \<1,000,000 IU/mL as measured by quantitative PCR
• Electrocardiogram (ECG) shows no acute ischemia or clinically significant abnormality and a QT/QTc interval \<450 milliseconds - using Bazett's correction: QTc =QT/RR0.5 (ICH Guidance E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs)
• Females of childbearing potential (intact uterus and within 1 year since the last menstrual period) should be non-lactating and have a negative serum pregnancy test. In addition, these subjects should agree to use one of the following acceptable birth control methods throughout the study:
• abstinence
• surgical sterilization (bilateral tubal ligation, hysterectomy, bilateral oophorectomy) six months minimum
• IUD in place for at least six months
• barrier methods (condom or diaphragm) with spermicide
• surgical sterilization of the partner (vasectomy for six months)
• hormonal contraceptives for at least three months prior to the first dose of study drug
• Willing and able to comply with study procedures and provide written informed consent

You may not qualify if:

• Participation in a clinical trial with or use of any investigational agent within 30 days of Study Visit 1
• Patients co-infected with HIV
• Patients with screening tests positive for HBsAg, or anti-HIV Ab
• Liver biopsy within the last 2 years that shows Stage III fibrosis or higher
• Clinical evidence or suspicion of cirrhosis
• Active jaundice defined by total bilirubin \>2.0
• INR ≥ 1.5
• Eating disorder or alcohol abuse within the past 2 years, excessive alcohol intake (\>20 g per day for females (1.5 standard alcohol drinks) or \>30 g per day for males (2.0 standard alcohol drinks) (a standard drink contains 14 g of alcohol: 12 oz of beer, 5 oz of wine or 1.5 oz of spirits) (1.0 fluid oz (US) = 29.57 ml), or if in the opinion of the investigator, an alcohol use pattern that will interfere with the study conduct
• Drug abuse within the last six months with the exception of cannabinoids and their derivatives
• Patients with absolute neutrophil count (ANC) \<1500 cells/mm3; platelet count \<135,000 cells/mm3; hemoglobin \<12 g/dL for women and \<13 g/dL for men; abnormal TSH,T4, or T3or thyroid function not adequately controlled; or serum creatinine concentration ≥1.5 times upper limit of normal (ULN)
• History or clinical evidence of any of the following:
• variceal bleeding, ascites, hepatic encephalopathy, CTP score \>6, decompensated liver disease or any other form of non-viral hepatitis
• immunologically mediated disease (e.g., rheumatoid arthritis, inflammatory bowel disease, severe psoriasis, systemic lupus erythematosus) requiring more than intermittent nonsteroidal anti-inflammatory medications for management or that requires frequent or prolonged use of corticosteroids (inhaled asthma medications are allowed)
• any malignancy within 3 years except for basal cell skin cancer
• significant or unstable cardiac disease (e.g., angina, congestive heart failure, uncontrolled hypertension, history of arrhythmia)

Sponsors & Collaborators

• Eiger BioPharmaceuticals: lead

Related Publications (1)

• Einav S, Gerber D, Bryson PD, Sklan EH, Elazar M, Maerkl SJ, Glenn JS, Quake SR. Discovery of a hepatitis C target and its pharmacological inhibitors by microfluidic affinity analysis. Nat Biotechnol. 2008 Sep;26(9):1019-27. doi: 10.1038/nbt.1490.

  PMID: 18758449 BACKGROUND

MeSH Terms

Conditions

Hepatitis C; Hepatitis

Condition Hierarchy (Ancestors)

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

Study Officials

• Jeffrey S Glenn, MD, PhD

  Eiger BioPharmaceuticals, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2009
• First Posted: July 24, 2009
• Study Start: July 1, 2009
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: April 15, 2021

Record last verified: 2021-04