Hepatitis C, ChronicNCT03764345
Eight Weeks Sofosbovir/Ledipasvir in HCV Infected Children Aged 4 to 10 Years
A study testing Sofosbovir/Lepipasvir (200/45mg) tablet (Heterosofir) in people with Hepatitis C, Chronic and 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 3 to 12 years
- Conditions the study is for
- Hepatitis C, Chronic, Children, Only
- What is being tested?
- Sofosbovir/Lepipasvir (200/45mg) tablet (Heterosofir)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 6 Dec 2018to 2 Jul 2019
- 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 3 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children with chronic HCV
- age 3- 12 y old
- weight 17- 35kg
- 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 3 years or above 12 years
- body weight less than 17 or more than 35 Kg
- HCV/HIV coinfection.
- Patients with HCV infection and HCC.
- Patients with HCV infection and underlying cardiac comorbidities
Show all 12Show fewer
- Decompensated patients with HCV
- Hypoalbuminemia of < 3.5g/dL.
- International normalised ratio (INR) >2.
- Advanced fibrosis scoring by transient elastography (F 4 broScan)
- 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, Gastroenterology and Nutrition Department, National Liver Institute, Menoufia University
Shebin El-Koom, Menofiya, 32511
About this study
Official title: Sofosbovir/Ledipasvir in HCV Infected Children Aged From 4 to 10 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 treat children aged between 3 and 12 years with half the adult dose of Sofosbuvir/Ledipasvir combination (Heterosofir).
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 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. Ap-proximately 90% of Egyptian HCV isolates belong to a single subtype, 4a.
Hepatitis C virus (HCV) is a major cause of chronic liver disease and a prin-cipal reason for liver transplant; approximately 170 million people worldwide are chronically infected. There is general consensus that HCV elimination is associated with strong and sustained CD4+ and CD8+ T cell res-ponses that target multiple epitopes within the different HCV proteins, however, they are not maintained in patients who develop chronic disease . A variety of factors purportedly contribute to the dimi-nished T cell responses observed in chronically infected patients, including an im-paired dendritic cell (DC) function.
The successful development of direct-acting antivirals (DAAs) that are active against hepatitis C virus has transformed chronic hepatitis C infection from a con-dition 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.
For adolescents aged 12-17 years, the safety and efficacy of the fixed-dose combination sofosbuvir and ledipasvir for genotype 1 or 4 infection and of combination sofosbuvir plus ribavirin for genotype 2 or 3 infection have been described in full-length articles.
A recent study explored the safety and efficacy of combination sofosbuvirplus ribavirin in Pakistani children (aged 5-18 years) with hepatitis C virus genotype 1, 2, or 3 infection. Further results have been presented as ab-stracts for the fixed-dose combination sofosbuvir and ledipasvir in children aged 6-11 years for the fixed-dose combination ombitasvir, pari-taprevir, and ritonavir with or without dasabuvir and with or without ribavirin in adolescents aged 12-17 years with genotype 1 or 4 infection and for combination sofosbuvir plus daclatasvir with or without ribavirin in Egyp-tian adolescents aged 12-17 years with genotype 4 infection.
Dendritic cells are professional antigen presenting cells characterized by a po-tent capacity to elicit primary T cell responses. Two major subsets of DC can be identified from human peripheral blood: plasmacytoid (p) DC and conventional or myeloid (m) DC. Each subset represents 0.3-0.5% of the normal human peripheral blood mononuclear cell (PBMC) population.
- Conditions
- Hepatitis C, Chronic, Children, Only
- Being tested
- Sofosbovir/Lepipasvir (200/45mg) tablet (Heterosofir)
- Medical subject headings
- Hepatitis C, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sofosbovir/Lepipasvir (200/45mg) tablet (Heterosofir)Drug
Patients receive oral daily dose of Sofosbovir/Ledipasvir (200/45mg) daily for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Sofosbovir/Ledipasvir Daily | Experimental | Patients receive oral daily dose of Sofosbovir/Ledipasvir (200/45mg) daily for 8 weeks Receives: Drug: Sofosbovir/Lepipasvir (200/45mg) tablet (Heterosofir) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Side effect 1 Number of patients with fatigue
Number of patients with fatigue
Measured: 8 weeks
Side effect 2 Number of patients with Headache
Number of patients with Headache
Measured: 8 weeks
Side effect 3 Number of patients with nausea
Number of patients with nausea
Measured: 8 weeks
Side effect 4 Number of patients with diarrhea
Number of patients with diarrhea
Measured: 8 weeks
Side effect 5 Number of patients with insomnia
Number of patients with insomnia
Measured: 8 weeks
Side effect 6 Number of patients with weakness
Number of patients with weakness
Measured: 8 weeks
Side effect 7 Number of patients with bradycardia
Number of patients with bradycardia
Measured: 8 weeks
Side effect 8 Number of patients with cough
Number of patients with cough
Measured: 8 weeks
Side effect 9 Number of patients with myalgia
Number of patients with myalgia
Measured: 8 weeks
Side effect 10 Number of patients with dysapnea
Number of patients with dysapnea
Measured: 8 weeks
Side effect 11 Number of patients with irritability
Number of patients with irritability
Measured: 8 weeks
Side effect 12 Number of patients with dizziness
Number of patients with dizziness
Measured: 8 weeks
Side effect 13 Number of patients with depression
Number of patients with depression
Measured: 8 weeks
Side effect 14 Number of patients with skin rash
Number of patients with skin rash
Measured: 8 weeks
Secondary outcomes (2)
HCV-RNA PCR by the end of therapy
HCV-RNA PCR at week 8
Measured: 8 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 posted5 Dec 2018
- Study start6 Dec 2018
- Primary completion2 Jul 2019
- Study completion2 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Hepatitis C, ChronicStudies 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Liver Institute, Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mostafa M. Sira, National Liver Institute, Egypt
- Investigators
- Behairy E Behairy, Prof, Principal investigator, National Liver Institute, Menoufia UniversityHanaa A El-Araby, Prof, Study director, National Liver Institute, Menoufia UniversityMohamed A El-Guindi, Prof, Study director, National Liver Institute, Menoufia UniversityHosam M Basiouny, MD, Study chair, National Liver Institute, Menoufia UniversityOla A Fouad, MD, Study chair, National Liver Institute, Menoufia UniversityAyman M Marey, Prof, Study chair, Faculty of Medicine, Zagazig UniversityBassam A Ayoub, MD, Study chair, National Liver Institute, Menoufia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03764345
- Sponsor's protocol ID
- Sof-Led-HCV-Ped
- Status last verified
- Sep 2019
- First submitted
- 28 Nov 2018
- Last updated
- 17 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Balistreri WF, Murray KF, Rosenthal P, Bansal S, Lin CH, Kersey K, Massetto B, Zhu Y, Kanwar B, German P, Svarovskaia E, Brainard DM, Wen J, Gonzalez-Peralta RP, Jonas MM, Schwarz K. The safety and effectiveness of ledipasvir-sofosbuvir in adolescents 12-17 years old with hepatitis C virus genotype 1 infection. Hepatology. 2017 Aug;66(2):371-378. doi: 10.1002/hep.28995. Epub 2017 Jun 19.
PubMed 27997679Deuffic-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 16310281El-Sayed M, Hassany M, Asem N. A pilot study for safety and efficacy of 12 weeks sofosbuvir plus daclatasvir with or without ribavirin in Egyptian adoles-cents with chronic hepatitis C virus Infection. Journal of Hepatology 2017,66:S178
El-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 12407579Gowans EJ, Jones KL, Bharadwaj M, Jackson DC. Prospects for dendritic cell vaccination in persistent infection with hepatitis C virus. J Clin Virol. 2004 Aug;30(4):283-90. doi: 10.1016/j.jcv.2004.03.006.
PubMed 15163415Hashmi MA, Cheema HA. Effectiveness and Safety of Sofosbuvir in Treatment-NaiveChildren with Hepatitis C Infection. J Coll Physicians Surg Pak. 2017 Jul;27(7):423-426.
PubMed 28818165Indolfi G, Serranti D, Resti M. Direct-acting antivirals for children and adolescents with chronic hepatitis C. Lancet Child Adolesc Health. 2018 Apr;2(4):298-304. doi: 10.1016/S2352-4642(18)30037-3. Epub 2018 Feb 24.
PubMed 30169301Kamal 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 10673085Murray KF, Balistreri W, Bansal S, Whitworth S, Evans H, Gonzalez-Peralta R, et al. Ledipasvir/sofosbuvir±ribavirin for 12 or 24 weeks is safe and effective in children 6-11 years old with chronic hepatitis C infection. Journal of Hepatology 2017,66:S57-S58
O'Doherty U, Peng M, Gezelter S, Swiggard WJ, Betjes M, Bhardwaj N, Steinman RM. Human blood contains two subsets of dendritic cells, one immunologically mature and the other immature. Immunology. 1994 Jul;82(3):487-93.
PubMed 7525461Takaki A, Wiese M, Maertens G, Depla E, Seifert U, Liebetrau A, Miller JL, Manns MP, Rehermann B. Cellular immune responses persist and humoral responses decrease two decades after recovery from a single-source outbreak of hepatitis C. Nat Med. 2000 May;6(5):578-82. doi: 10.1038/75063.
PubMed 10802716Thorne 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 27482412Wirth S, Rosenthal P, Gonzalez-Peralta RP, Jonas MM, Balistreri WF, Lin CH, Hardikar W, Kersey K, Massetto B, Kanwar B, Brainard DM, Shao J, Svarovskaia E, Kirby B, Arnon R, Murray KF, Schwarz KB. Sofosbuvir and ribavirin in adolescents 12-17 years old with hepatitis C virus genotype 2 or 3 infection. Hepatology. 2017 Oct;66(4):1102-1110. doi: 10.1002/hep.29278. Epub 2017 Aug 26.
PubMed 28543053Schulze Zur Wiesch J, Ciuffreda D, Lewis-Ximenez L, Kasprowicz V, Nolan BE, Streeck H, Aneja J, Reyor LL, Allen TM, Lohse AW, McGovern B, Chung RT, Kwok WW, Kim AY, Lauer GM. Broadly directed virus-specific CD4+ T cell responses are primed during acute hepatitis C infection, but rapidly disappear from human blood with viral persistence. J Exp Med. 2012 Jan 16;209(1):61-75. doi: 10.1084/jem.20100388. Epub 2012 Jan 2.
PubMed 22213804
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sofosbovir/Ledipasvir in HCV Infected Children Aged From 4 to 10 Years
- ClinicalTrials.gov ID
- NCT03764345
- Acronym / sponsor ID
- Sof-Led-HCV-Ped
- Conditions
- Hepatitis C, Chronic, Children, Only
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- National Liver Institute, EgyptUniversity, hospital or other
- Study start
- 6 Dec 2018 (actual)
- Primary completion
- 2 Jul 2019 (actual)
- Study completion
- 2 Jul 2019 (actual)
- First posted
- 5 Dec 2018 (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 treat children aged between 3 and 12 years with half the adult dose of Sofosbuvir/Ledipasvir combination (Heterosofir).
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 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. Ap-proximately 90% of Egyptian HCV isolates belong to a single subtype, 4a.
Hepatitis C virus (HCV) is a major cause of chronic liver disease and a prin-cipal reason for liver transplant; approximately 170 million people worldwide are chronically infected. There is general consensus that HCV elimination is associated with strong and sustained CD4+ and CD8+ T cell res-ponses that target multiple epitopes within the different HCV proteins, however, they are not maintained in patients who develop chronic disease . A variety of factors purportedly contribute to the dimi-nished T cell responses observed in chronically infected patients, including an im-paired dendritic cell (DC) function.
The successful development of direct-acting antivirals (DAAs) that are active against hepatitis C virus has transformed chronic hepatitis C infection from a con-dition 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.
For adolescents aged 12-17 years, the safety and efficacy of the fixed-dose combination sofosbuvir and ledipasvir for genotype 1 or 4 infection and of combination sofosbuvir plus ribavirin for genotype 2 or 3 infection have been described in full-length articles.
A recent study explored the safety and efficacy of combination sofosbuvirplus ribavirin in Pakistani children (aged 5-18 years) with hepatitis C virus genotype 1, 2, or 3 infection. Further results have been presented as ab-stracts for the fixed-dose combination sofosbuvir and ledipasvir in children aged 6-11 years for the fixed-dose combination ombitasvir, pari-taprevir, and ritonavir with or without dasabuvir and with or without ribavirin in adolescents aged 12-17 years with genotype 1 or 4 infection and for combination sofosbuvir plus daclatasvir with or without ribavirin in Egyp-tian adolescents aged 12-17 years with genotype 4 infection.
Dendritic cells are professional antigen presenting cells characterized by a po-tent capacity to elicit primary T cell responses. Two major subsets of DC can be identified from human peripheral blood: plasmacytoid (p) DC and conventional or myeloid (m) DC. Each subset represents 0.3-0.5% of the normal human peripheral blood mononuclear cell (PBMC) population.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sofosbovir/Ledipasvir Daily | Experimental | Drug: Sofosbovir/Lepipasvir (200/45mg) tablet (Heterosofir)Patients receive oral daily dose of Sofosbovir/Ledipasvir (200/45mg) daily for 8 weeks |
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Children with chronic HCV
- age 3- 12 y old
- weight 17- 35kg
- Basal HCV viremia less than 6.8 log IU/mL
- Treatment-naive
Key exclusion criteria (12 listed)
- Patients with dual HBV and HCV infection or associated with chronic hepatitis other than chronic HCV
- age below 3 years or above 12 years
- body weight less than 17 or more than 35 Kg
- HCV/HIV coinfection.
- Patients with HCV infection and HCC.
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 |
|---|---|---|
| Sofosbovir/Lepipasvir (200/45mg) tablet (Heterosofir)Patients receive oral daily dose of Sofosbovir/Ledipasvir (200/45mg) daily for 8 weeks | Drug | Sofosbovir/Ledipasvir Daily |
Primary outcome
Side effect 1 Number of patients with fatigue
Time frame: 8 weeks
Number of patients with fatigue
Side effect 2 Number of patients with Headache
Time frame: 8 weeks
Number of patients with Headache
Side effect 3 Number of patients with nausea
Time frame: 8 weeks
Number of patients with nausea
Side effect 4 Number of patients with diarrhea
Time frame: 8 weeks
Number of patients with diarrhea
Side effect 5 Number of patients with insomnia
Time frame: 8 weeks
Number of patients with insomnia
Side effect 6 Number of patients with weakness
Time frame: 8 weeks
Number of patients with weakness
Side effect 7 Number of patients with bradycardia
Time frame: 8 weeks
Number of patients with bradycardia
Side effect 8 Number of patients with cough
Time frame: 8 weeks
Number of patients with cough
Side effect 9 Number of patients with myalgia
Time frame: 8 weeks
Number of patients with myalgia
Side effect 10 Number of patients with dysapnea
Time frame: 8 weeks
Number of patients with dysapnea
Side effect 11 Number of patients with irritability
Time frame: 8 weeks
Number of patients with irritability
Side effect 12 Number of patients with dizziness
Time frame: 8 weeks
Number of patients with dizziness
Side effect 13 Number of patients with depression
Time frame: 8 weeks
Number of patients with depression
Side effect 14 Number of patients with skin rash
Time frame: 8 weeks
Number of patients with skin rash
2 secondary outcomes
HCV-RNA PCR by the end of therapy
Time frame: 8 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 17 Sep 2019.
- Background: PubMed 27997679Balistreri WF, Murray KF, Rosenthal P, Bansal S, Lin CH, Kersey K, Massetto B, Zhu Y, Kanwar B, German P, Svarovskaia E, Brainard DM, Wen J, Gonzalez-Peralta RP, Jonas MM, Schwarz K. The safety and effectiveness of ledipasvir-sofosbuvir in adolescents 12-17 years old with hepatitis C virus genotype 1 infection. Hepatology. 2017 Aug;66(2):371-378. doi: 10.1002/hep.28995. Epub 2017 Jun 19.
- Background: 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.
- BackgroundEl-Sayed M, Hassany M, Asem N. A pilot study for safety and efficacy of 12 weeks sofosbuvir plus daclatasvir with or without ribavirin in Egyptian adoles-cents with chronic hepatitis C virus Infection. Journal of Hepatology 2017,66:S178
- Background: 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.
- Background: PubMed 15163415Gowans EJ, Jones KL, Bharadwaj M, Jackson DC. Prospects for dendritic cell vaccination in persistent infection with hepatitis C virus. J Clin Virol. 2004 Aug;30(4):283-90. doi: 10.1016/j.jcv.2004.03.006.
- Background: PubMed 28818165Hashmi MA, Cheema HA. Effectiveness and Safety of Sofosbuvir in Treatment-NaiveChildren with Hepatitis C Infection. J Coll Physicians Surg Pak. 2017 Jul;27(7):423-426.
- Background: PubMed 30169301Indolfi G, Serranti D, Resti M. Direct-acting antivirals for children and adolescents with chronic hepatitis C. Lancet Child Adolesc Health. 2018 Apr;2(4):298-304. doi: 10.1016/S2352-4642(18)30037-3. Epub 2018 Feb 24.
- Background: 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.
- BackgroundMurray KF, Balistreri W, Bansal S, Whitworth S, Evans H, Gonzalez-Peralta R, et al. Ledipasvir/sofosbuvir±ribavirin for 12 or 24 weeks is safe and effective in children 6-11 years old with chronic hepatitis C infection. Journal of Hepatology 2017,66:S57-S58
- Background: PubMed 7525461O'Doherty U, Peng M, Gezelter S, Swiggard WJ, Betjes M, Bhardwaj N, Steinman RM. Human blood contains two subsets of dendritic cells, one immunologically mature and the other immature. Immunology. 1994 Jul;82(3):487-93.
- Background: PubMed 10802716Takaki A, Wiese M, Maertens G, Depla E, Seifert U, Liebetrau A, Miller JL, Manns MP, Rehermann B. Cellular immune responses persist and humoral responses decrease two decades after recovery from a single-source outbreak of hepatitis C. Nat Med. 2000 May;6(5):578-82. doi: 10.1038/75063.
- Background: 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.
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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.
Behairy E Behairy, Prof principal investigator
National Liver Institute, Menoufia University
Hanaa A El-Araby, Prof study director
National Liver Institute, Menoufia University
Mohamed A El-Guindi, Prof 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 Sofosbovir/Lepipasvir (200/45mg) tablet (Heterosofir) in people with Hepatitis C, Chronic and 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 12 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 17 Sep 2019. 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 1 Number of patients with fatigue (time frame: 8 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 NCT03764345, which also lists 14 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 17 Sep 2019.