NCT00945880 (CLEAN-1) is a Phase 1 clinical trial of clemizole hydrochloride in Hepatitis C, sponsored by Eiger BioPharmaceuticals.

Who is sponsoring NCT00945880?

NCT00945880 is sponsored by Eiger BioPharmaceuticals.

What drugs are being tested in NCT00945880?

Interventions in NCT00945880: clemizole hydrochloride.

What condition does NCT00945880 study?

NCT00945880 studies Hepatitis C.

Is NCT00945880 still recruiting?

NCT00945880 is currently completed. Last updated 13 April 2021.

Last reviewed 2021-04-13 · How we verify

NCT00945880: CLEAN-1

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 1 Last updated 13 April 2021

What this trial tests

Phase 1 trial testing clemizole hydrochloride in Hepatitis C in 12 participants. Completed in 1 August 2010.

Timeline

1 July 2009

Primary endpoint
1 August 2010

1 August 2010

Quick facts

Lead sponsor	Eiger BioPharmaceuticals
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	12
Start date	1 July 2009
Primary completion	1 August 2010
Estimated completion	1 August 2010

Drugs / interventions tested

clemizole hydrochloride

Conditions studied

Hepatitis C — all drugs for Hepatitis C →

Sponsor

Eiger BioPharmaceuticals — full company profile →

Who can join

Adults 18 to 55, any sex, with Hepatitis C. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

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

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Mixing the right hepatitis C inhibitor cocktail.
Gelman MA, Glenn JS. · · 2011 · cited 26× · PMID 21106440 · DOI 10.1016/j.molmed.2010.10.005
The Future of HCV Therapy: NS4B as an Antiviral Target.
Dvory-Sobol H, Pang PS, Glenn JS. · · 2010 · cited 21× · PMID 21157574 · DOI 10.3390/v2112481
Clemizole hydrochloride blocks cardiac potassium currents stably expressed in HEK 293 cells.
Jie LJ, Wu WY, Li G, Xiao GS, et al · · 2017 · cited 12× · PMID 27886373 · DOI 10.1111/bph.13679

Verify or expand the search:

Other recruiting trials for Hepatitis C

Currently open trials in the same condition.

NCT06263829 — HCV Tappt Adherence Study · NA · recruiting
NCT06179498 — Partner Navigation Intervention for Hepatitis C Treatment Among Young People Who Inject Drugs · NA · recruiting
NCT06367465 — Feasibility and Acceptability of HCV Treatment in Pregnancy · recruiting
NCT05668780 — Buprenorphine Integration Research and Community Health · NA · active not recruiting
NCT05208697 — Tele-Harm Reduction · NA · active not recruiting

Other Eiger BioPharmaceuticals trials

Trials by the same sponsor.

NCT05070364 — Phase 3 Study to Evaluate the Efficacy and Safety of Peginterferon Lambda for 48 Weeks in Patients With Chronic HDV · Phase 3 · unknown
NCT03719313 — Study of the Efficacy and Safety of Lonafarnib / Ritonavir With and Without Pegylated Interferon -Alfa-2a · Phase 3 · completed
NCT03373435 — Safety and Efficacy of Exendin 9-39 in Patients With Postbariatric Hypoglycemia · Phase 2 · completed
NCT02765802 — A Study to Evaluate Pegylated Interferon Lambda Monotherapy in Patients With Chronic Hepatitis Delta Virus Infection · Phase 2 · completed
NCT03895528 — Lonafarnib for Patients With Hutchinson-Gilford Progeria Syndrome or Progeroid Laminopathy · approved for marketing

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00945880 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Eiger BioPharmaceuticals
Last refreshed: 13 April 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00945880.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing