Hepatitis CPhase 1CLEAN-1NCT00945880
Safety and Tolerability Study of Clemizole Hydrochloride to Treat Hepatitis C in Subjects Who Are Treatment-Naive
A Phase 1 study testing clemizole hydrochloride in people with Hepatitis C, run by Eiger BioPharmaceuticals.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Hepatitis C
- What is being tested?
- clemizole hydrochloride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- Jul 2009to Aug 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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
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- 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)
- chronic pulmonary disease (e.g., chronic obstructive pulmonary disease) associated with functional impairment
- severe or uncontrolled psychiatric disease, including severe depression, history of suicidal ideation, suicidal attempts or psychosis requiring medication and/or hospitalization
- Patients with a body mass index >30 kg/m2
- Concomitant drugs known to prolong the QT interval (see Appendix E)
- Concomitant use of immunosuppressive or immune modulating agents
- Patients with any serious or condition that, in the opinion of the investigator, would preclude evaluation of response or make it unlikely that the contemplated course of therapy and follow-up could be completed or increase the risk to the subject of participation in the trial
About this study
Official title: A Phase 1b, Open Label Study of the Safety, Tolerability Pharmacokinetics and Pharmacodynamics of 100 mg Clemizole Hydrochloride Administered Orally Twice a Day for 28 Days Immediately Prior to Initiation of Treatment With HCV Standard of Care Therapy in Treatment-Naïve Subjects Chronically Infected With HCV
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.
Read the detailed description
This study is a phase 1b, open label study of four weeks of treatment with 100 mg po BID of clemizole hydrochloride administered immediately prior to the initiation of treatment with HCV standard of care therapy consisting of pegylated interferon and ribavirin in treatment-naïve subjects chronically infected with HCV genotype 1 or genotype 2. The duration of the study for each subject will be approximately 11 weeks (up to three week screening period, four week treatment period and four week safety follow-up period). The duration of the entire study is anticipated to be approximately four months (first subject in to last subject out). Pharmacokinetic sampling will be done at Day 1 and Day 28 of dosing. PK sampling will be conducted only on subjects who have consented to participate in the PK portion of this study. Participation in PK sampling is optional for each subject.
- Conditions
- Hepatitis C
- Being tested
- clemizole hydrochloride
- Keywords
- HCV, Hepatitis C, Hepatitis
- Medical subject headings
- Hepatitis C, Hepatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clemizole hydrochlorideDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | clemizole hydrochloride, 100mg, BID Receives: Drug: clemizole hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the pharmacodynamic (PD) activity of a 100 mg po BID dose of clemizole hydrochloride on HCV viral load
Measured: 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
Measured: 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
Measured: Day 1, 2, 3, 7, 14, 28, 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2009 (estimated)
- Study startJul 2009
- Primary completionAug 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eiger BioPharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jeffrey S Glenn, MD, PhD, Study director, Eiger BioPharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00945880
- Sponsor's protocol ID
- EIG-101
- Acronym
- CLEAN-1
- Status last verified
- Apr 2021
- First submitted
- 23 Jul 2009
- Last updated
- 15 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 18758449
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b, Open Label Study of the Safety, Tolerability Pharmacokinetics and Pharmacodynamics of 100 mg Clemizole Hydrochloride Administered Orally Twice a Day for 28 Days Immediately Prior to Initiation of Treatment With HCV Standard of Care Therapy in Treatment-Naïve Subjects Chronically Infected With HCV
- ClinicalTrials.gov ID
- NCT00945880
- Acronym / sponsor ID
- CLEAN-1 / EIG-101
- Conditions
- Hepatitis C
- Keywords
- HCV, Hepatitis C, Hepatitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Eiger BioPharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jul 2009
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 24 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study is a phase 1b, open label study of four weeks of treatment with 100 mg po BID of clemizole hydrochloride administered immediately prior to the initiation of treatment with HCV standard of care therapy consisting of pegylated interferon and ribavirin in treatment-naïve subjects chronically infected with HCV genotype 1 or genotype 2. The duration of the study for each subject will be approximately 11 weeks (up to three week screening period, four week treatment period and four week safety follow-up period). The duration of the entire study is anticipated to be approximately four months (first subject in to last subject out). Pharmacokinetic sampling will be done at Day 1 and Day 28 of dosing. PK sampling will be conducted only on subjects who have consented to participate in the PK portion of this study. Participation in PK sampling is optional for each subject.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Drug: clemizole hydrochlorideclemizole hydrochloride, 100mg, BID |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| clemizole hydrochlorideTwo 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 | Drug | Experimental Group |
Primary outcome
Evaluate the pharmacodynamic (PD) activity of a 100 mg po BID dose of clemizole hydrochloride on HCV viral load
Time frame: Day 1, 3, 7, 14, 28, 56
2 secondary outcomes
Evaluate the pharmacokinetics (PK) of a 100 mg po BID dose of clemizole hydrochloride in subjects chronically infected with HCV
Time frame: 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
Time frame: Day 1, 2, 3, 7, 14, 28, 56
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2021.
- Background: PubMed 18758449Einav 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey S Glenn, MD, PhD study director
Eiger BioPharmaceuticals, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing clemizole hydrochloride in people with Hepatitis C, run by Eiger BioPharmaceuticals.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the pharmacodynamic (PD) activity of a 100 mg po BID dose of clemizole hydrochloride on HCV viral load (time frame: Day 1, 3, 7, 14, 28, 56). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00945880, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2021.