NCT00493610

Brief Summary

The study will examine the effects of treatment with N-acetylcysteine ( Mucomyst ) 1 gm twice a day for 30 dyas in 15 patients with hepatitis C. The primary outcome of interest wil be the changes in oxidant stress as measured by different oxidant stress markers level in sera. Secondary outcomes of interest will be changes in viral load of hep C and changes in liver function

Trial Health

33
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
5

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2006

Geographic Reach
1 country

1 active site

Status
suspended

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2006

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

June 26, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 28, 2007

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
Last Updated

January 8, 2010

Status Verified

June 1, 2008

Enrollment Period

1.6 years

First QC Date

June 26, 2007

Last Update Submit

January 7, 2010

Conditions

Hepatitis C

Keywords

Oxidant stressN-acetylcysteineHepatitis CLiver diseaseMucomystIsoprostane

Outcome Measures

Primary Outcomes (1)

  • Measurable oxidant stress

    30 days

Secondary Outcomes (1)

  • Reduction in viral load of Hep C and changes in Liver Function tests

    30 days

Study Arms (1)

1

OTHER
Drug: N-acetylcysteine(Mucomyst)

Interventions

N-acetylcysteine(Mucomyst)DRUG
1

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- Patient with known hepatitis C

You may not qualify if:

  • Patient on another therapy for Hep C
  • Patient on dialysis
  • Patient who are allergic to Mucomyst

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Medical Center, Dayton

Dayton, Ohio, 45428, United States

Location

MeSH Terms

Conditions

Hepatitis CLiver Diseases

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisDigestive System Diseases

Study Officials

  • Mohammad G. Saklayen, MD

    VA Medical Center, Dayton

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
FED

Study Record Dates

First Submitted

June 26, 2007

First Posted

June 28, 2007

Study Start

November 1, 2006

Primary Completion

June 1, 2008

Study Completion

June 1, 2008

Last Updated

January 8, 2010

Record last verified: 2008-06

Locations

US(1)