Treatment of Egyptian Hepatitis C Genotype 4 Infected Children (and Adolescents) With Combined Sofosbuvir & Daclatasvir
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ClinicalTrials.gov Identifier: NCT03080415 |
Recruitment Status :
Completed
First Posted : March 15, 2017
Last Update Posted : June 6, 2018
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Condition or disease | Intervention/treatment | Phase |
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Hepatitis C Genotype 4 | Drug: Combined Therapy SOF and DCV | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 40 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Intervention Model Description: | All of the participants will be receiving combined therapy of sofosbuvir and daclatasvir for 12 weeks. |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | The Safety and Efficacy of Sofosbuvir & Daclatasvir Combined Therapy for Treatment of Egyptian Children and Adolescents With Chronic Hepatitis C (HCV)-Genotype 4 |
Actual Study Start Date : | March 18, 2017 |
Actual Primary Completion Date : | February 18, 2018 |
Actual Study Completion Date : | May 18, 2018 |

Arm | Intervention/treatment |
---|---|
Experimental: Combined Therapy SOF and DCV |
Drug: Combined Therapy SOF and DCV
1 whole or half tablet sofosbuvir and 1 whole or half tablet daclatasvir per day SOF dosage: 400 mg/day for greater than 45 kg weight patients; 200 mg/day for 17 kg to 45 kg patients DCV dosage: 60 mg/day for greater than 45 kg weight patients; 30 mg for 17 kg to 45 kg patients Other Names:
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- 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.

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Ages Eligible for Study: | 8 Years to 18 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age: 8-18 years
- Sex: both sexes
- Naïve patients, with chronic HCV infection
Exclusion Criteria:
- Co-infection with Hepatitis B virus (HBV)
- Other associated chronic liver illness
- Cirrhotic patients (as indicated by biopsy, fibroscan(F4)
- Patients with history of hematemesis (non cirrhotic portal hypertension)
- Patients on drugs known to interact unfavorably with SOF (Amiodarone,..)

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): NCT03080415
Egypt | |
Professor Yassin Abdel Ghaffar Charity Center for Liver Disease and Research | |
Nasr City, Cairo, Egypt |
Principal Investigator: | Tawhida Y. Abdel Ghaffar, M.D. | Professor Yassin Abdel Ghaffar Charity Center for Liver Disease and Research |
Responsible Party: | Dr. Tawhida Yassin Abdel Ghaffar, Professor, Yassin Abdelghaffar Charity Center for Liver Disease and Research |
ClinicalTrials.gov Identifier: | NCT03080415 |
Other Study ID Numbers: |
DCV SOF T 2017 |
First Posted: | March 15, 2017 Key Record Dates |
Last Update Posted: | June 6, 2018 |
Last Verified: | June 2018 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Hepatitis A Hepatitis C Hepatitis Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Infections Enterovirus Infections |
Picornaviridae Infections RNA Virus Infections Blood-Borne Infections Communicable Diseases Flaviviridae Infections Sofosbuvir Antiviral Agents Anti-Infective Agents |