No registrations found.
ID
Source
Brief title
Health condition
Chronic hepatitis C genotype 4.
Sponsors and support
Intervention
Outcome measures
Primary outcome
Sustained viral response 12 weeks after the end of therapy (SVR12) in on-treatment study population.
Secondary outcome
SVR12 in ITT study population
SVR12 in the population with < 6 million IU/ml HCV RNA
SVR12 in the population with HCV RNA < limit of detection at week 4
SVR12 in HIV negative population compared to SVR12 in HIV positive population
Study objective
OBJECTIVE: To document that a 8 week treatment with Ledipasvir-Sofosbuvir in patients chronically infected with HCV genotype 4 but without liver cirrhosis is effective.
Study design
Screening, Baseline, Week 4, Week 8 (end of therapy), Week 20 (SVR12).
Intervention
Ledipasvir and Sofosbuvir, 8 weeks
Anne Boerekamps
Rotterdam
The Netherlands
Trial-telefoon: 06-12725005
a.boerekamps@erasmusmc.nl
Anne Boerekamps
Rotterdam
The Netherlands
Trial-telefoon: 06-12725005
a.boerekamps@erasmusmc.nl
Inclusion criteria
1. ¡Ý18 years
2. Chronic HCV genotype 4 infection according to definition mentioned below
3. F0-3 with biopsy or fibroscan result (stiffness <12.5 kPa) ¡Ü24 months old for F0-2 and <12 months old for F3
4. HVC viral load < 10 million IU/ml, ¡Ü6 months old.
Definition of chronic hepatitis C infection: The diagnosis of chronic hepatitis C is based on the detection of both anti-HCV antibodies or HCV RNA present for more than 6 months. Since, in the case of a newly acquired HCV infection, spontaneous viral clearance is rare after the first 6months of infection, the diagnosis of chronic hepatitis C can be made at that time (as stated in the EASL clinical practice guideline ¡°Recommendations on treatment of hepatitis C 2015¡±).
Exclusion criteria
1. HCV viral load >10 million IU/ml
2. Fibroscan >12.5 Kpa or F4 on liver biopsy or signs of portal hypertension or liver cirrhosis on imaging
3. Disallowed co-medication that cannot be stopped or replaced: Therefore ALL co-medication, including over-the-counter drugs should be checked for potential drug-drug interactions using the summary of product characteristics (appendix A). When in doubt about drug-drug interactions, contact the coordinating investigator.
4. eGFR < 30 ml/min
5. Previous therapy with any DAA for current HCV genotype 4 infection
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL5622 |
| NTR-old | NTR5729 |
| CCMO | NL56571.078.16 |
| OMON | NL-OMON43387 |