Eight Weeks Sofosbovir/Ledipasvir in HCV Infected Children Aged 4 to 10 Years

NCT03764345 | Completed

• 1 other identifier: Sof-Led-HCV-Ped
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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. The current study aimed to treat children aged between 3 and 12 years with half the adult dose of Sofosbuvir/Ledipasvir combination (Heterosofir).

Conditions

Hepatitis C, Chronic; Children, Only

Outcome Measures

Primary Outcomes (14)

• Side effect 1 Number of patients with fatigue

  Number of patients with fatigue

  8 weeks

• Side effect 2 Number of patients with Headache

  Number of patients with Headache

  8 weeks

• Side effect 3 Number of patients with nausea

  Number of patients with nausea

  8 weeks

• Side effect 4 Number of patients with diarrhea

  Number of patients with diarrhea

  8 weeks

• Side effect 5 Number of patients with insomnia

  Number of patients with insomnia

  8 weeks

• Side effect 6 Number of patients with weakness

  Number of patients with weakness

  8 weeks

• Side effect 7 Number of patients with bradycardia

  Number of patients with bradycardia

  8 weeks

• Side effect 8 Number of patients with cough

  Number of patients with cough

  8 weeks

• Side effect 9 Number of patients with myalgia

  Number of patients with myalgia

  8 weeks

• Side effect 10 Number of patients with dysapnea

  Number of patients with dysapnea

  8 weeks

• Side effect 11 Number of patients with irritability

  Number of patients with irritability

  8 weeks

• Side effect 12 Number of patients with dizziness

  Number of patients with dizziness

  8 weeks

• Side effect 13 Number of patients with depression

  Number of patients with depression

  8 weeks

• Side effect 14 Number of patients with skin rash

  Number of patients with skin rash

  8 weeks

Secondary Outcomes (2)

• HCV-RNA PCR by the end of therapy

  8 weeks

• HCV-RNA PCR after 20 weeks for SVR

  20 weeks

Other Outcomes (5)

• Treatment safety-1 Alanine transaminase serum level

  8 weeks

• Treatment safety-2 Aspartate transaminase serum level

  8 weeks

• Treatment safety-2 Degree of liver fibrosis

  8 weeks

Study Arms (1)

Sofosbovir/Ledipasvir Daily

EXPERIMENTAL

Patients receive oral daily dose of Sofosbovir/Ledipasvir (200/45mg) daily for 8 weeks

Drug: Sofosbovir/Lepipasvir (200/45mg) tablet (Heterosofir)

Interventions

Sofosbovir/Lepipasvir (200/45mg) tablet (Heterosofir) DRUG

Patients receive oral daily dose of Sofosbovir/Ledipasvir (200/45mg) daily for 8 weeks

Sofosbovir/Ledipasvir Daily

Eligibility Criteria

• Age: 3 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• National Liver Institute, Egypt: lead

Study Sites (1)

Pediatric Hepatology, Gastroenterology and Nutrition Department, National Liver Institute, Menoufia University

Shebin El-Koom, Menofiya, 32511, Egypt

Location

Related Publications (14)

• 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.

  PMID: 27997679 BACKGROUND

• Deuffic-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.

  PMID: 16310281 BACKGROUND

• El-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

• 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.

  PMID: 12407579 BACKGROUND

• Gowans 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.

  PMID: 15163415 BACKGROUND

• Hashmi 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.

  PMID: 28818165 BACKGROUND

• Indolfi 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.

  PMID: 30169301 BACKGROUND

• Kamal 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.

  PMID: 10673085 BACKGROUND

• Murray 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

• 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.

  PMID: 7525461 BACKGROUND

• Takaki 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.

  PMID: 10802716 BACKGROUND

• Thorne 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.

  PMID: 27482412 BACKGROUND

• Wirth 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.

  PMID: 28543053 BACKGROUND

• Schulze 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.

  PMID: 22213804 BACKGROUND

MeSH Terms

Conditions

Hepatitis C, Chronic

Interventions

Tablets

Condition Hierarchy (Ancestors)

Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Study Officials

• Behairy E Behairy, Prof

  National Liver Institute, Menoufia University

  PRINCIPAL INVESTIGATOR

• Hanaa A El-Araby, Prof

  National Liver Institute, Menoufia University

  STUDY DIRECTOR

• Mohamed A El-Guindi, Prof

  National Liver Institute, Menoufia University

  STUDY DIRECTOR

• Hosam M Basiouny, MD

  National Liver Institute, Menoufia University

  STUDY CHAIR

• Ola A Fouad, MD

  National Liver Institute, Menoufia University

  STUDY CHAIR

• Ayman M Marey, Prof

  Faculty of Medicine, Zagazig University

  STUDY CHAIR

• Bassam A Ayoub, MD

  National Liver Institute, Menoufia University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 28, 2018
• First Posted: December 5, 2018
• Study Start: December 6, 2018
• Primary Completion: July 2, 2019
• Study Completion: July 2, 2019
• Last Updated: September 17, 2019

Record last verified: 2019-09

Locations

EG (1)