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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT02628691 |
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Date of registration:
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25/11/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Monitoring Liver Disease Progression in Hepatitis C/HIV Co-infected Patients With No-to-moderate Fibrosis, in Phnom Penh, Cambodia
HCV-Monitoring |
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Scientific title:
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Monitoring Liver Disease Progression in Hepatitis C/HIV Co-infected Patients With No-to-moderate Fibrosis, in Phnom Penh, Cambodia (HCV-Monitoring) |
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Date of first enrolment:
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December 17, 2015 |
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Target sample size:
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70 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT02628691 |
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Study type:
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Observational |
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Study design:
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Phase:
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N/A
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Countries of recruitment
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Cambodia
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Contacts
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Name:
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An Sokkab, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Sihanouk Hospital Center of HOPE (SHCH), Cambodia |
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Name:
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Anja De Weggheleire, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Institute of Tropical Medicine, Antwerp, Belgium |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Male and females
- =18 years
- Documented HIV infection
- Evidence of infection with hepatitis C virus (all genotypes): Positive anti-HCV
antibody and HCV RNA
- Absence of advanced liver disease or clinical signs of extra-hepatic disease:
- F0-F2 (< 9,5 kPa) established by transient elastography, and
- No clinical signs of extra-hepatic disease
- Not on HCV antiviral treatment
Exclusion Criteria:
- Currently on/or history of hepatitis C treatment
- Patients with initial fibrosis stage = F3 (= 9,5 kPA on transient elastography)
- Patients not able/willing to adhere to the consultation, laboratory and liver
stiffness measurement testing schedule as proposed in this study
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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HIV
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Hepatitis C
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Intervention(s)
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Other: Liver fibrosis progression
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Primary Outcome(s)
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Short-term progression to advanced liver fibrosis
[Time Frame: 30 months]
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Secondary Outcome(s)
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Laboratory characteristics
[Time Frame: Baseline]
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Clinical characteristics
[Time Frame: Baseline]
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Diagnostic accuracy of non-invasive serum bio-markers: FIB-4
[Time Frame: 30 months]
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Liver stiffness measurement
[Time Frame: 30 months]
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Progression to cirrhosis
[Time Frame: 30 months]
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Changes in fibrosis stage scores
[Time Frame: 30 months]
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Predictive factors for liver fibrosis progression
[Time Frame: 30 months]
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Demographic characteristics
[Time Frame: Baseline]
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Diagnostic accuracy of non-invasive serum bio-markers: APRI
[Time Frame: 30 months]
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Secondary ID(s)
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HCV-Monitoring
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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