Ignite Creation Date:
2025-12-26 @ 11:12 PM
Ignite Modification Date:
2026-03-09 @ 10:45 AM
Study NCT ID:
NCT03540212
Status:
UNKNOWN
Last Update Posted:
2023-03-06
First Post:
2018-02-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Pharmacokinetics of Daclatasvir/Sofosbuvir in Adolescents With Hepatitis C Virus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C549273', 'term': 'daclatasvir'}, {'id': 'D000069474', 'term': 'Sofosbuvir'}], 'ancestors': [{'id': 'D014542', 'term': 'Uridine Monophosphate'}, {'id': 'D014500', 'term': 'Uracil Nucleotides'}, {'id': 'D011742', 'term': 'Pyrimidine Nucleotides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009711', 'term': 'Nucleotides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D012265', 'term': 'Ribonucleotides'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-12-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2023-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-03-03', 'studyFirstSubmitDate': '2018-02-23', 'studyFirstSubmitQcDate': '2018-05-27', 'lastUpdatePostDateStruct': {'date': '2023-03-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measurement of the pharmacokinetics of DCV-SOF', 'timeFrame': 'Blood samples will be collected on day 8 of therapy', 'description': 'Blood samples (3 mL) will be collected to measure dactalasvir concentrations from pediatric patients using a nine-point plasma schedule (pre-dose, 0.5,1, 2, 4, 8, 12, and 24 h post-dose) on day 8 of therapy.\n\n(This will be a total of 27 mL/patient, which is well below the maximum allowed internationally recognized value of blood loss is 2.4mL/kg in a 4 month period. Any deviations from nominal sampling times should be recorded.\n\nAUCtau which is defined as the concentration of drug over time (area under the plasma concentration versus time curve over the dosing interval will be calculated'}], 'secondaryOutcomes': [{'measure': 'Measurement of Number of Participants With sustained virological response (SVR12), 12 weeks after discontinuation of therapy with daclatasvir-sofosbuvir (DCV-SOF).', 'timeFrame': '12 weeks after discontinuation of therapy with daclatasvir-sofosbuvir (DCV-SOF).', 'description': 'Number of Participants With sustained virological response at 12 Weeks after end of study drug treatment (SVR12) will be recorded, participant will be considered to have achieved SVR12 if HCV RNA is less than the lower limit of quantification of \\<15 IU/ml) at 12 weeks after the end of treatment.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic HCV Infection']}, 'referencesModule': {'references': [{'pmid': '32367815', 'type': 'DERIVED', 'citation': 'Al-Nahari MM, Abbassi MM, Ebeid FS, Hassany M, El-Sayed MH, Farid SF. Pharmacokinetics of daclatasvir in Egyptian adolescents with genotype-4 HCV infection. Antivir Ther. 2020;25(2):101-110. doi: 10.3851/IMP3357.'}]}, 'descriptionModule': {'briefSummary': 'This is an interventional Phase II/III, single center, single arm clinical trial to assess the pharmacokinetics, efficacy, safety and tolerance of daclatasvir plus sofosbuvir in treatment-naïve, non-cirrhotic adolescents with chronic HCV GT-4 infection.\n\nA single-arm evaluation of daclatasvir/sofosbuvir will focus on the pharmacokinetics, efficacy and safety\n\nAll enrolled patients will receive daclatasvir 60 mg orally once daily plus sofosbuvir at a dose of 400 mg orally once daily for 12 weeks.', 'detailedDescription': "This is an interventional Phase II/III, single center, single arm clinical trial to assess the pharmacokinetics efficacy, safety, and tolerance of daclatasvir plus sofosbuvir in treatment-naïve, non-cirrhotic adolescents with chronic HCV GT-4 infection.\n\nA single-arm evaluation of daclatasvir/sofosbuvir will focus on the efficacy, safety and pharmacokinetics, confirm the favorable pharmacological profile.\n\nAll enrolled patients will receive daclatasvir 60 mg orally once daily plus sofosbuvir at a dose of 400 mg orally once daily for 12 weeks.\n\nPatients will be followed closely for disease progression and any hypersensitivity or adverse reactions due to therapy. Laboratory values to be monitored at baseline: Serum creatinine, bilirubin, AST, ALT, HCV viral load (VL).\n\nFifty patients will be included; the first twenty patients will be candidates for pharmacokinetic assessment. All patients (50), will be candidates for safety and efficacy assessment after verifying the PK results ''phase II''. Patients will be recruited at Ain Shams University hospitals, Egypt. The study will be conducted after approval of the corresponding research ethical committee and obtaining an informed consent from the parents/guardians and an assent from the patients.\n\nPatients will be requested to come for 2 screening visits, at the first day of therapy, weekly during the first four weeks, at the end of week 8 and week 12. Patients who will complete their treatment schedule will be scheduled for a visit after 12 weeks from end of therapy for assessment of sustained virological response (SVR). The total number of visits are 9. Duration of follow up will be 24 weeks from treatment initiation in addition to the screening period (2-4 weeks)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Adolescents (ages 12- 18 years) and/ or weight ≥ 35 kg\n2. HCV genotype 4 infected\n3. Naïve non-cirrhotic population with FIB Score: F0 to F3.\n4. Screening laboratory values within define thresholds\n5. Both sex\n6. Evidence of HCV infection determined by positive anti-HCV antibody and HCV RNA by polymerase chain reaction (PCR)\n7. HCV treatment-naïve\n8. Absolute neutrophil count ≥ 1,500/mm3\n9. Hemoglobin level ≥ 10 g/dL\n10. Platelets \\> 75000 cells/mm3\n11. Albumin \\> 3.5 mg/dL\n12. PT \\< 3 sec above control and INR within accepted range\n13. Random glucose level within normal range\n14. Serum creatinine \\< 1.5 mg/dL\n15. Biopsy is not required for study entry.\n16. Signing informed consent by parents and patient assent\n\nExclusion Criteria:\n\n1. Previous treatment for HCV.\n2. History of clinically significant illness or any other medical condition that may interfere with individuals' treatment, assessment, or compliance with protocol.\n3. Co-infection with HIV, acute hepatitis A virus, or hepatitis B virus\n4. Clinical hepatic decompensation (i.e., ascites, encephalopathy or variceal hemorrhage)\n5. Pregnant or nursing females\n6. Use of any illicit concomitant medications as within 28 days of the Day 1\n7. Renal dysfunction\n8. Ongoing treatment with Prohibited drugs.\n9. Chronic liver disease due to a cause other than HCV e.g. autoimmune disease, Wilson disease,…etc.\n10. Alfa-fetoprotein level \\>50 ng/mL\n11. Serum creatinine \\>1.5 mg/dL\n12. Simultaneous acute hepatitis A infection\n13. Known hypersensitivity to daclatasvir or sofosbuvir\n14. History of gastrointestinal disease or surgical procedure\n15. Blood /blood product transfusion within 4 weeks prior to study\n16. Systemic corticosteroid use for more than 2 weeks (pulmonary/nasal administration was permitted)\n17. Psychiatric hospitalization, suicide attempt or disability resulting from psychiatric illness within the prior 5 years\n18. Clinically relevant alcohol or drug abuse within 12 months of screening\n19. Ongoing treatment with any medications interacting with daclatasvir/sofosbuvir"}, 'identificationModule': {'nctId': 'NCT03540212', 'briefTitle': 'Clinical Pharmacokinetics of Daclatasvir/Sofosbuvir in Adolescents With Hepatitis C Virus', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Clinical Pharmacokinetics, Safety and Efficacy Study of Daclatasvir/Sofosbuvir in Adolescents Aged 12 to 18 Years Old With Hepatitis C Virus: A Preliminary Study', 'orgStudyIdInfo': {'id': 'FMASU P69a/2017'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Daclatasvir and sofosbuvir', 'description': 'Daclatasvir and sofosbuvir\n\nSingle arm intervention open label trial for single tablet (Daclatasvir 90 mg and Sofosbuvir 400mg and ) Daclatasvir 90 mg for 12 weeks', 'interventionNames': ['Drug: Daclatasvir and sofosbuvir']}], 'interventions': [{'name': 'Daclatasvir and sofosbuvir', 'type': 'DRUG', 'otherNames': ['DCV-SOF', 'Sofosbuvir-Daclatasvir'], 'description': 'Daclatasvir is a DAAs that can inhibit the HCV non-structural (NS) 5A protein when used in combination with other HCV-therapies. It has a linear, non-time-dependent pharmacokinetic profile and nanomolar potency in vitro against HCV genotypes 1-6. It is excreted primarily via faeces, about 88% in an unchanged form while renal excretion accounts for approximately 7% of its elimination.\n\nDOSE OF SOFOSBUVIR: 400 mg tablet orally once daily with food (in the morning) for 12 weeks for adolescents with liver fibrosis Metavir score F0-F2.\n\nDOSE OF DACLTASVIR: 60 mg tablet orally once daily with food (in the morning) for 12 weeks for adolescents with liver fibrosis Metavir score F0-F2.', 'armGroupLabels': ['Daclatasvir and sofosbuvir']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11556', 'city': 'Cairo', 'state': 'Non-US', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Manal H El-Sayed, MD', 'role': 'CONTACT', 'email': 'mamalhelsayed@yahoo.co.uk', 'phone': '00201227461120'}, {'name': 'Fatma Soliman E Ebeid, MD', 'role': 'CONTACT', 'email': 'dr.fatma_ebeid@yahoo.com', 'phone': '1095569596', 'phoneExt': 'Ebeid'}, {'name': 'Manal H El-Sayed, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Fatma SE Ebeid, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Aya M Kamal, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Mohamed Hassany, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Mogeb M Saif, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Samar F Farid', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Maggie M Abbassi', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Sara Makkeyah, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Mary Akhnokh, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Pediatric Department, Faculty of Medicine, Ain Shams University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Manal H El-Sayed, MD', 'role': 'CONTACT', 'email': 'manalhelsayed@yahoo.co.uk', 'phone': '00201227461120'}, {'name': 'Fatma SE Ebeid, MD', 'role': 'CONTACT', 'email': 'dr.fatma_ebeid@yahoo.com', 'phone': '00201095569596'}], 'overallOfficials': [{'name': 'Manal H El-Sayed, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Professor of Pediatric, Faculty of Medicine, Ain Shams University, Egypt'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Pediatrics', 'investigatorFullName': 'Manal Hamdy El-Sayed', 'investigatorAffiliation': 'Ain Shams University'}}}}