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Ledipasvir and sofosbuvir for 8 weeks for the treatment of chronic hepatitis C genotype 4 in patients without cirrhosis.


- candidate number24114
- NTR NumberNTR5729
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR15-mrt-2016
- Secondary IDsNL56571.078.16 
- Public TitleLedipasvir and sofosbuvir for 8 weeks for the treatment of chronic hepatitis C genotype 4 in patients without cirrhosis.
- Scientific TitleLedipasvir and sofosbuvir for 8 weeks for the treatment of chronic hepatitis C genotype 4 in patients without cirrhosis
- ACRONYMHepNed-001
- hypothesisOBJECTIVE: To document that a 8 week treatment with Ledipasvir-Sofosbuvir in patients chronically infected with HCV genotype 4 but without liver cirrhosis is effective.
- Healt Condition(s) or Problem(s) studiedChronic hepatitis C
- Inclusion criteria1. ¡İ18 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 criteria1. 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
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeintervention
- planned startdate 10-mrt-2016
- planned closingdate31-dec-2017
- Target number of participants41
- InterventionsLedipasvir and Sofosbuvir, 8 weeks
- Primary outcomeSustained viral response 12 weeks after the end of therapy (SVR12) in on-treatment study population.
- Secondary outcomeSVR12 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
- TimepointsScreening, Baseline, Week 4, Week 8 (end of therapy), Week 20 (SVR12).
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDrs. Anne Boerekamps
- CONTACT for SCIENTIFIC QUERIES Bart Rijnders
- Sponsor/Initiator Erasmus Medical Center
- Funding
(Source(s) of Monetary or Material Support)
None
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD15-mrt-2016 - 16-mei-2016


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