Treatment of Egyptian Hepatitis C Genotype 4 Infected Children and Adolescents With Combined Ledipasvir/Sofosbuvir
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|ClinicalTrials.gov Identifier: NCT03743727|
Recruitment Status : Recruiting
First Posted : November 16, 2018
Last Update Posted : November 16, 2018
|Condition or disease||Intervention/treatment||Phase|
|Hepatitis C Genotype 4||Drug: Combined therapy LDV and SOF||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed-Dose Combination for Treatment of Egyptian Children and Adolescents With Chronic Hepatitis C (HCV)-Genotype 4|
|Actual Study Start Date :||August 1, 2018|
|Estimated Primary Completion Date :||March 30, 2019|
|Estimated Study Completion Date :||June 30, 2019|
|Experimental: Combined Therapy LDV and SOF||
Drug: Combined therapy LDV and SOF
All patients will receive ledipasvir/sofosbuvir fixed dose combination for 12 weeks. Patients weighing 35 kg or more will receive the adult dose: ledipasvir (90 mg)/sofosbuvir (400 mg). Patients weighing below 35 kg will receive half the adult dose: ledipasvir (45 mg)/sofosbuvir (200 mg).
Other Name: ledipasvir and sofosbuvir
- Incidence of Treatment Emergent Adverse Events [ Time Frame: During the 12 weeks of treatment. ]The presence of any adverse effects will be used to characterize this outcome measure.
- Sustained Viral Clearance [ Time Frame: At Week 12 after end of treatment. ]HCV RNA qPCR will be used to determine if the target of viral clearance has been established. Detection limit of the kit is 12 IU/ml.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03743727
|Contact: Mamdouh A. Ahmedemail@example.com|
|Professor Yassin Abdel Ghaffar Charity Center for Liver Disease and Research||Recruiting|
|Nasr City, Cairo, Egypt|
|Contact: Mamdouh A. Ahmed 02-01221707770 firstname.lastname@example.org|
|Principal Investigator:||Tawhida Y. Abdel Ghaffar, MD||Yassin Abdel Ghaffar Charity Center for Liver Disease and Research|