Hepatitis C,Chronic Children, OnlyNCT07905989
Twelve Weeks Sofosbuvir/Daclatasvir in HCV Infected Children Aged 6-18 Years
A study testing Sofosbuvir/Daclatasvir in people with Hepatitis C,Chronic Children, Only, run by National Liver Institute, Egypt at 1 site in Egypt.
Trial summary
Recently the era of direct-acting antiviral drugs for hepatitis C treatment has changed the world map of HCV. Results in adults are promising. FDA approved only two drugs in the pediatric age group 12 to 17 years. Younger children are still on the wait list for treatment. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Hepatitis C,Chronic Children, Only
- What is being tested?
- Sofosbuvir/Daclatasvir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteEgypt
- Study dates
- 18 Dec 2023to 25 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children with chronic HCV
- Age 6-18 y old
- Must be able to swallow tablets
- Basal HCV viremia less than 6.8 log IU/ml
- Treatment -naive
- No cirrhosis
Who cannot join
- Patients with dual HBV and HCV infection or associated with chronic hepatitis other than chronic HCV Age below 6 years or above 18 years HCV/HIV coinfection. Patients with HCV infection and HCC Patients with HCV infection and underlying cardiac comorbidities Decompensated patients with HCV Hypoalbuminemia of <3.5 g/dl International normalized ratio (INR)>2. Advanced fibrosis scoring by transient elastography (F4 fibroscan) Any concomitant malignancy. Parents' refusal for participation of their children in the study.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Pediatric Hepatology, Gastroentrology and Nutrition Department, National Liver Institute, Menoufia University
Cairo, Menoufia, 32511
About this study
Official title: Safety and Efficacy of Sofosbuvir / Daclatasvir in Children With HCV Aged 6-18 Years
Recently the era of direct-acting antiviral drugs for hepatitis C treatment has changed the world map of HCV. Results in adults are promising. FDA approved only two drugs in the pediatric age group 12 to 17 years. Younger children are still on the wait list for treatment. The current study aimed to study the efficacy and safety of combined sofosbuvir (SOF)/daclatasvir (DCV) in children with hepatitis C virus infection aged 6-18 years.
Read the detailed description
The WHO has declared hepatitis C a global health problem, with ∼ 3% of the world's population (roughly 170-200 million individuals) infected with Hepatitis C virus (HCV). Egypt has the highest prevalence of HCV in the world, ranging from 6 to 28%, with an average of ∼ 13.8% in the general population. Approximately 90% of Egyptian HCV isolates belong to a single subtype, 4a .
Hepatitis C virus is a major cause of chronic liver disease and a principal reason for liver transplant; approximately 170 million people worldwide are chronically infected . The successful development of direct-acting antivirals (DAAs) that are active against hepatitis C virus has transformed chronic hepatitis C infection from a condition requiring complex therapies with unsatisfactory outcomes to one that can be easily treated with few contraindications and side-effects. Since 2011, the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have approved eight oral DAA regimens for the treatment of adults with chronic hepatitis C. Investigation into DAAs for children has been slower .
Combination therapies with highly effective DAA regimes, such as sofos-buvir/ledipasvir, sofosbuvir/velpatasvir, glecaprevir/pibrentasvir, sofos-buvir/daclatasvir, sofosbuvir/ribavirin and others, are available for use in children. Most of the DAA regimens have either received or are pending to receive regulatory approval by different medical/drug agencies for use in children and adolescents. Pan-genotypic regimens are also available in children and adolescents, and these regimens can be used while skipping genotype testing.
Previous study found that daclatasvir 30 mg once daily was predicted to achieve effective and safe exposures in children 14 to <35 kg, perhaps down to 10 kg.
Other study revealed that combined sofosbuvir (SOF)/daclatasvir (DCV) for HCV Genotype 4 in children aged 8 to 18 years or weighing 17 kg or more was found to be effective and safe .
Also other study tested the effects of dual sofosbuvir/daclatasvir (SOF/DCV) therapy in the treatment of chronic HCV in survivors of hematologic malignancy in pediatric age group and found that SOF/DCV combined therapy could be used safely and effectively in the treatment of chronic HCV genotype-4 infection in leukemia/lymphoma treated children
- Conditions
- Hepatitis C,Chronic Children, Only
- Being tested
- Sofosbuvir/Daclatasvir
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sofosbuvir/DaclatasvirDrug
Patients weighted less than 35 kg receive oral daily dose of Sofosbuvir/Daclatasvir (200/30 mg) daily for 12 weeks. Patients weighted more than or equal to 35 kg receive oral daily dose of Sofosbuvir/Daclatasvir (400/60 mg) daily for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Sofosbuvir/Daclatasvir Daily | Experimental | Patients weighted less than 35 kg receive oral daily dose of Sofosbuvir/Daclatasvir (200/30mg) daily for 12 weeks. Patients weighted more than or equal 35 kg receive oral daily dose of Sofosbuvir/Daclatasvir (400/60mg) daily for 12 weeks Receives: Drug: Sofosbuvir/Daclatasvir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Side effect 2 Number of patients with Headache
Number of patients with Headache
Measured: 12 weeks
Side effect 1 Number of patients with fatigue
Number of patients with fatigue
Measured: 12 weeks
Side effect 3 Number of patients with nausea
Number of patients with nausea
Measured: 12 weeks
Side effect 4 Number of patients with diarrhea
Number of patients with diarrhea
Measured: 12 weeks
Side effect 5 Number of patients with insomnia
Number of patients with insomnia
Measured: 12 weeks
Side effect 6 Number of patients with weakness
Number of patients with weakness
Measured: 12 weeks
Side effect 7 Number of patients with bradycardia
Number of patients with bradycardia
Measured: 12 weeks
Side effect 8 Number of patients with cough
Number of patients with cough
Measured: 12 weeks
Side effect 9 Number of patients with myalgia
Number of patients with myalgia
Measured: 12 weeks
Side effect 10 Number of patients with dyspnea
Number of patients with dyspnea
Measured: 12 weeks
Side effect 11 Number of patients with irritability
Number of patients with irritability
Measured: 12 weeks
Side effect 12 Number of patients with dizziness
Number of patients with dizziness
Measured: 12 weeks
Side effect 13 Number of patients with depression
Number of patients with depression
Measured: 12 weeks
Side effect 14 Number of patients with skin rash
Number of patients with skin rash
Measured: 12 weeks
Secondary outcomes (2)
HCV-RNA PCR by the end of therapy
HCV-RNA PCR at week 12
Measured: 12 weeks
HCV-RNA PCR after 20 weeks for SVR
HCV-RNA PCR at week 20
Measured: 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2026
- Study start18 Dec 2023
- Primary completion25 Jul 2024
- Study completion25 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Hepatitis C,Chronic Children, OnlyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Liver Institute, Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nermin M Adawy, Prof, Principal investigator, National Liver Institute, Menoufia UniversityHosam M Basiouny, MD, Study director, National Liver Institute, Menoufia UniversityOla A Fouad, MD, Study director, National Liver Institute, Menoufia UniversityHowyda A El-Bhwashy, MD, Study director, National Liver Institute, Menoufia UniversityShaimaa G Hegazy, MSC, Study director, National Liver Institute, Menoufia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07905989
- Sponsor's protocol ID
- Sof-Dac-HCV-Ped 6-18 Years
- Status last verified
- May 2026
- First submitted
- 22 Jun 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Plan to Share IPD
Publications
Venkatesh V, Seetharaman K, Anushree N. Treatment of hepatitis C in children and adolescents: how far have we reached? World J Pediatr. 2023 Feb;19(2):107-119. doi: 10.1007/s12519-022-00612-7. Epub 2022 Sep 21.
PubMed 36129634Cressey TR, Abbassi M, Lallemant M, Indolfi G, Al-Nahari M, Farid S, Penazzato M, Easterbrook P, El-Sayed MH. Effective and Safe Daclatasvir Drug Exposures Predicted in Children Using Adult Formulations. Pediatr Infect Dis J. 2021 Dec 1;40(12):1081-1086. doi: 10.1097/INF.0000000000003282.
PubMed 34321444Abdel Ghaffar TY, El Naghi S, Abdel Gawad M, Helmy S, Abdel Ghaffar A, Yousef M, Moafy M. Safety and efficacy of combined sofosbuvir/daclatasvir treatment of children and adolescents with chronic hepatitis C Genotype 4. J Viral Hepat. 2019 Feb;26(2):263-270. doi: 10.1111/jvh.13032. Epub 2018 Dec 7.
PubMed 30380158El-Shabrawi MH, Sherief LM, Yakoot M, Kamal NM, Almalky MA, AbdElgawad MM, Mahfouz AA, Helmy S, Kamal EM, Attia D, El-Khayat HR. Effects of dual sofosbuvir/daclatasvir therapy on, chronic hepatitis C infected, survivors of childhood malignancy. World J Clin Cases. 2019 Aug 26;7(16):2247-2255. doi: 10.12998/wjcc.v7.i16.2247.
PubMed 31531319Thorne C, Indolfi G, Turkova A, Giaquinto C, Nastouli E. Treating hepatitis C virus in children: time for a new paradigm. J Virus Erad. 2015 Jul 1;1(3):203-5. doi: 10.1016/S2055-6640(20)30500-8.
PubMed 27482412El-Serag HB. Hepatocellular carcinoma and hepatitis C in the United States. Hepatology. 2002 Nov;36(5 Suppl 1):S74-83. doi: 10.1053/jhep.2002.36807.
PubMed 12407579Kamal SM, Madwar MA, Peters T, Fawzy R, Rasenack J. Interferon therapy in patients with chronic hepatitis C and schistosomiasis. J Hepatol. 2000 Jan;32(1):172-4. doi: 10.1016/s0168-8278(00)80207-x. No abstract available.
PubMed 10673085Deuffic-Burban S, Mohamed MK, Larouze B, Carrat F, Valleron AJ. Expected increase in hepatitis C-related mortality in Egypt due to pre-2000 infections. J Hepatol. 2006 Mar;44(3):455-61. doi: 10.1016/j.jhep.2005.08.008. Epub 2005 Sep 15.
PubMed 16310281
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Sofosbuvir / Daclatasvir in Children With HCV Aged 6-18 Years
- ClinicalTrials.gov ID
- NCT07905989
- Acronym / sponsor ID
- Sof-Dac-HCV-Ped 6-18 Years
- Conditions
- Hepatitis C,Chronic Children, Only
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- National Liver Institute, EgyptUniversity, hospital or other
- Study start
- 18 Dec 2023 (actual)
- Primary completion
- 25 Jul 2024 (actual)
- Study completion
- 25 Jul 2024 (actual)
- First posted
- 30 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Recently the era of direct-acting antiviral drugs for hepatitis C treatment has changed the world map of HCV. Results in adults are promising. FDA approved only two drugs in the pediatric age group 12 to 17 years. Younger children are still on the wait list for treatment. The current study aimed to study the efficacy and safety of combined sofosbuvir (SOF)/daclatasvir (DCV) in children with hepatitis C virus infection aged 6-18 years.
Detailed description
The WHO has declared hepatitis C a global health problem, with ∼ 3% of the world's population (roughly 170-200 million individuals) infected with Hepatitis C virus (HCV). Egypt has the highest prevalence of HCV in the world, ranging from 6 to 28%, with an average of ∼ 13.8% in the general population. Approximately 90% of Egyptian HCV isolates belong to a single subtype, 4a .
Hepatitis C virus is a major cause of chronic liver disease and a principal reason for liver transplant; approximately 170 million people worldwide are chronically infected . The successful development of direct-acting antivirals (DAAs) that are active against hepatitis C virus has transformed chronic hepatitis C infection from a condition requiring complex therapies with unsatisfactory outcomes to one that can be easily treated with few contraindications and side-effects. Since 2011, the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have approved eight oral DAA regimens for the treatment of adults with chronic hepatitis C. Investigation into DAAs for children has been slower .
Combination therapies with highly effective DAA regimes, such as sofos-buvir/ledipasvir, sofosbuvir/velpatasvir, glecaprevir/pibrentasvir, sofos-buvir/daclatasvir, sofosbuvir/ribavirin and others, are available for use in children. Most of the DAA regimens have either received or are pending to receive regulatory approval by different medical/drug agencies for use in children and adolescents. Pan-genotypic regimens are also available in children and adolescents, and these regimens can be used while skipping genotype testing.
Previous study found that daclatasvir 30 mg once daily was predicted to achieve effective and safe exposures in children 14 to <35 kg, perhaps down to 10 kg.
Other study revealed that combined sofosbuvir (SOF)/daclatasvir (DCV) for HCV Genotype 4 in children aged 8 to 18 years or weighing 17 kg or more was found to be effective and safe .
Also other study tested the effects of dual sofosbuvir/daclatasvir (SOF/DCV) therapy in the treatment of chronic HCV in survivors of hematologic malignancy in pediatric age group and found that SOF/DCV combined therapy could be used safely and effectively in the treatment of chronic HCV genotype-4 infection in leukemia/lymphoma treated children
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sofosbuvir/Daclatasvir Daily | Experimental | Drug: Sofosbuvir/DaclatasvirPatients weighted less than 35 kg receive oral daily dose of Sofosbuvir/Daclatasvir (200/30mg) daily for 12 weeks. Patients weighted more than or equal 35 kg receive oral daily dose of Sofosbuvir/Daclatasvir (400/60mg) daily for 12 weeks |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Children with chronic HCV
- Age 6-18 y old
- Must be able to swallow tablets
- Basal HCV viremia less than 6.8 log IU/ml
- Treatment -naive
Key exclusion criteria (1 listed)
- Patients with dual HBV and HCV infection or associated with chronic hepatitis other than chronic HCV Age below 6 years or above 18 years HCV/HIV coinfection. Patients with HCV infection and HCC Patients with HCV infection and underlying cardiac comorbidities Decompensated patients with HCV Hypoalbuminemia of <3.5 g/dl International normalized ratio (INR)>2. Advanced fibrosis scoring by transient elastography (F4 fibroscan) Any concomitant malignancy. Parents' refusal for participation of their children in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sofosbuvir/DaclatasvirPatients weighted less than 35 kg receive oral daily dose of Sofosbuvir/Daclatasvir (200/30 mg) daily for 12 weeks. Patients weighted more than or equal to 35 kg receive oral daily dose of Sofosbuvir/Daclatasvir (400/60 mg) daily for 12 weeks | Drug | Sofosbuvir/Daclatasvir Daily |
Primary outcome
Side effect 2 Number of patients with Headache
Time frame: 12 weeks
Number of patients with Headache
Side effect 1 Number of patients with fatigue
Time frame: 12 weeks
Number of patients with fatigue
Side effect 3 Number of patients with nausea
Time frame: 12 weeks
Number of patients with nausea
Side effect 4 Number of patients with diarrhea
Time frame: 12 weeks
Number of patients with diarrhea
Side effect 5 Number of patients with insomnia
Time frame: 12 weeks
Number of patients with insomnia
Side effect 6 Number of patients with weakness
Time frame: 12 weeks
Number of patients with weakness
Side effect 7 Number of patients with bradycardia
Time frame: 12 weeks
Number of patients with bradycardia
Side effect 8 Number of patients with cough
Time frame: 12 weeks
Number of patients with cough
Side effect 9 Number of patients with myalgia
Time frame: 12 weeks
Number of patients with myalgia
Side effect 10 Number of patients with dyspnea
Time frame: 12 weeks
Number of patients with dyspnea
Side effect 11 Number of patients with irritability
Time frame: 12 weeks
Number of patients with irritability
Side effect 12 Number of patients with dizziness
Time frame: 12 weeks
Number of patients with dizziness
Side effect 13 Number of patients with depression
Time frame: 12 weeks
Number of patients with depression
Side effect 14 Number of patients with skin rash
Time frame: 12 weeks
Number of patients with skin rash
2 secondary outcomes
HCV-RNA PCR by the end of therapy
Time frame: 12 weeks
HCV-RNA PCR after 20 weeks for SVR
Time frame: 20 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Results publication: PubMed 36129634Venkatesh V, Seetharaman K, Anushree N. Treatment of hepatitis C in children and adolescents: how far have we reached? World J Pediatr. 2023 Feb;19(2):107-119. doi: 10.1007/s12519-022-00612-7. Epub 2022 Sep 21.
- Results publication: PubMed 34321444Cressey TR, Abbassi M, Lallemant M, Indolfi G, Al-Nahari M, Farid S, Penazzato M, Easterbrook P, El-Sayed MH. Effective and Safe Daclatasvir Drug Exposures Predicted in Children Using Adult Formulations. Pediatr Infect Dis J. 2021 Dec 1;40(12):1081-1086. doi: 10.1097/INF.0000000000003282.
- Results publication: PubMed 30380158Abdel Ghaffar TY, El Naghi S, Abdel Gawad M, Helmy S, Abdel Ghaffar A, Yousef M, Moafy M. Safety and efficacy of combined sofosbuvir/daclatasvir treatment of children and adolescents with chronic hepatitis C Genotype 4. J Viral Hepat. 2019 Feb;26(2):263-270. doi: 10.1111/jvh.13032. Epub 2018 Dec 7.
- Results publication: PubMed 31531319El-Shabrawi MH, Sherief LM, Yakoot M, Kamal NM, Almalky MA, AbdElgawad MM, Mahfouz AA, Helmy S, Kamal EM, Attia D, El-Khayat HR. Effects of dual sofosbuvir/daclatasvir therapy on, chronic hepatitis C infected, survivors of childhood malignancy. World J Clin Cases. 2019 Aug 26;7(16):2247-2255. doi: 10.12998/wjcc.v7.i16.2247.
- Results publication: PubMed 27482412Thorne C, Indolfi G, Turkova A, Giaquinto C, Nastouli E. Treating hepatitis C virus in children: time for a new paradigm. J Virus Erad. 2015 Jul 1;1(3):203-5. doi: 10.1016/S2055-6640(20)30500-8.
- Results publication: PubMed 12407579El-Serag HB. Hepatocellular carcinoma and hepatitis C in the United States. Hepatology. 2002 Nov;36(5 Suppl 1):S74-83. doi: 10.1053/jhep.2002.36807.
- Results publication: PubMed 10673085Kamal SM, Madwar MA, Peters T, Fawzy R, Rasenack J. Interferon therapy in patients with chronic hepatitis C and schistosomiasis. J Hepatol. 2000 Jan;32(1):172-4. doi: 10.1016/s0168-8278(00)80207-x. No abstract available.
- Results publication: PubMed 16310281Deuffic-Burban S, Mohamed MK, Larouze B, Carrat F, Valleron AJ. Expected increase in hepatitis C-related mortality in Egypt due to pre-2000 infections. J Hepatol. 2006 Mar;44(3):455-61. doi: 10.1016/j.jhep.2005.08.008. Epub 2005 Sep 15.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Plan to Share IPD
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nermin M Adawy, Prof principal investigator
National Liver Institute, Menoufia University
Hosam M Basiouny, MD study director
National Liver Institute, Menoufia University
Ola A Fouad, MD study director
National Liver Institute, Menoufia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sofosbuvir/Daclatasvir in people with Hepatitis C,Chronic Children, Only, run by National Liver Institute, Egypt at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Side effect 2 Number of patients with Headache (time frame: 12 weeks). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07905989, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.