NCT00749138

Brief Summary

A short 14 day phase 1 study examining 6 monotherapy doses of oral tamoxifen for safety in chronic HCV patients who have failed standard treatment of peginterferon and ribavirin.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Nov 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 4, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 9, 2008

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2008

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
Last Updated

March 9, 2010

Status Verified

March 1, 2010

Enrollment Period

6 months

First QC Date

September 4, 2008

Last Update Submit

March 7, 2010

Conditions

Chronic Hepatitis C

Keywords

hepatitis C, tamoxifen

Outcome Measures

Primary Outcomes (1)

  • No significant changes in ALT or total bilirubin

    14 days

Secondary Outcomes (1)

  • HCV RNA reduction

    14 days

Study Arms (1)

tamoxifen

EXPERIMENTAL

open label giving of tamoxifen

Drug: tamoxifen

Interventions

tamoxifenDRUG

giving drug tamoxifen

Also known as: Nolvadex
tamoxifen

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • HCV RNA positive.
  • failed standard therapy

You may not qualify if:

  • Cirrhosis on biopsy
  • Severe medical or psychiatric conditions that would make the evaluation difficult
  • Tamoxifen is a pregnancy category D drug so pregnant women must be excluded.
  • Patients with coumadin cannot be used from a drug interaction.
  • Active use of alcohol or illegal substances -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Hospital

Oklahoma City, Oklahoma, 73104, United States

Location

MeSH Terms

Conditions

Hepatitis C, ChronicHepatitis C

Interventions

Tamoxifen

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

StilbenesBenzylidene CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Ted Bader

    OUHSC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDIV

Study Record Dates

First Submitted

September 4, 2008

First Posted

September 9, 2008

Study Start

November 1, 2008

Primary Completion

May 1, 2009

Study Completion

October 1, 2009

Last Updated

March 9, 2010

Record last verified: 2010-03

Locations

US(1)