- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02613871
Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed-Dose Combination in Adults With Chronic HCV and HBV Coinfection
A Phase 3b Open-Label Study of Ledipasvir/Sofosbuvir Fixed-Dose Combination for 12 Weeks in Subjects With Chronic Genotype 1 or 2 Hepatitis C Virus (HCV) and Hepatitis B Virus (HBV) Coinfection
Studieoversigt
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 3
Kontakter og lokationer
Studiesteder
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Changhua, Taiwan
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Chiayi City, Taiwan
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Kaohsiung, Taiwan
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Kaohsiung City, Taiwan
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Keelung, Taiwan
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Taichung, Taiwan
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Tainan, Taiwan
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Tainan City, Taiwan
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Taipei, Taiwan
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Taipei City, Taiwan
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Taoyuan, Taiwan
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Key Inclusion Criteria:
- Individuals ≥ 40 kg in weight with chronic genotype 1 or 2 HCV and HBV coinfection
- Individuals must not be taking or requiring treatment with HBV antiviral therapy at screening. For participants that are HBV treatment experienced, the most recent treatment must have been completed at least 6 months prior to Day 1.
- Cirrhosis determination by Fibroscan
- Screening laboratory values within defined thresholds
- Use of two effective contraception methods if female or male is of childbearing potential
Key Exclusion Criteria:
- Current or prior history of clinically-significant illness or any other major medical disorder that may interfere with individual's treatment, assessment or compliance with the protocol
- Pregnant or nursing female
- Infection with human immunodeficiency virus (HIV) or hepatitis delta virus (HDV)
- Hepatocellular carcinoma (HCC) or other malignancy
- Current or prior history of clinical hepatic decompensation
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: LDV/SOF
LDV/SOF FDC for 12 weeks
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90/400 mg FDC tablet indgivet oralt én gang dagligt
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
Tidsramme: Posttreatment Week 12
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SVR12 was defined as HCV RNA < the lower limit of quantification (LLOQ; 15 IU/mL) at 12 weeks after stopping study treatment.
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Posttreatment Week 12
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Percentage of Participants With Any Adverse Event Leading to Permanent Discontinuation of Study Drug
Tidsramme: First dose date up to 12 weeks
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First dose date up to 12 weeks
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)
Tidsramme: Posttreatment Week 4
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SVR4 was defined as HCV RNA < LLOQ (15 IU/mL) at 4 weeks after stopping study treatment.
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Posttreatment Week 4
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Percentage of Participants With HCV RNA < LLOQ While on Treatment
Tidsramme: Weeks 1, 2, 4, 8, and 12
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LLOQ = 15 IU/mL
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Weeks 1, 2, 4, 8, and 12
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Percentage of Participants With HCV RNA < LLOQ at Posttreatment Weeks 24, 36, 48, 60, 72, 84, 96, and 108
Tidsramme: Posttreatment Weeks 24, 36, 48, 60, 72, 84, 96, and 108
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LLOQ = 15 IU/mL
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Posttreatment Weeks 24, 36, 48, 60, 72, 84, 96, and 108
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HCV RNA Change From Baseline While on Treatment
Tidsramme: Weeks 1, 2, 4, 8, and 12
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Weeks 1, 2, 4, 8, and 12
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Percentage of Participants With Virologic Failure
Tidsramme: First dose date up to Posttreatment Week 12
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Virologic failure was defined as :
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First dose date up to Posttreatment Week 12
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Plasma HBV DNA Change From Baseline While on Treatment
Tidsramme: Weeks 1, 2, 4, 8, and 12
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Weeks 1, 2, 4, 8, and 12
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Plasma HBV DNA Change From Baseline at Posttreatment Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, and 108
Tidsramme: Posttreatment Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, and 108
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Posttreatment Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, and 108
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HBsAg Level Change From Baseline While on Treatment
Tidsramme: Weeks 1, 2, 4, 8, and 12
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Weeks 1, 2, 4, 8, and 12
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HBsAg Level Change From Baseline at Posttreatment Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, and 108
Tidsramme: Posttreatment Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, and 108
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Posttreatment Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, and 108
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Serum LOXL-2 Level Change From Baseline While on Treatment
Tidsramme: Weeks 1, 2, 4, 8, and 12
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Weeks 1, 2, 4, 8, and 12
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Serum LOXL-2 Level Change From Baseline at Posttreatment Weeks 4, 12, and 36
Tidsramme: Posttreatment Weeks 4, 12, and 36
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Posttreatment Weeks 4, 12, and 36
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Percentage of Participants That Required HBV Therapy During the Study
Tidsramme: First dose date up to Posttreatment Week 108
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First dose date up to Posttreatment Week 108
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Fibrosis Status as Assessed by Fibroscan Score at Posttreatment Weeks 12, 60, and 108
Tidsramme: Posttreatment Weeks 12, 60, and 108
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FibroScan is a non-invasive device that assesses the hardness (or stiffness) of the liver using the technique of transient elastography. FibroScan results range from 2.5 kPa to 75 kPa with higher scores indicating greater liver stiffness. Per protocol, cirrhosis status was determined as follows:
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Posttreatment Weeks 12, 60, and 108
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Percentage of Participants That Develop Hepatocellular Carcinoma (HCC) During the Study
Tidsramme: First dose date up to Posttreatment Week 108
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First dose date up to Posttreatment Week 108
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Samarbejdspartnere og efterforskere
Sponsor
Publikationer og nyttige links
Generelle publikationer
- Liu CJ, Chuang WL, Sheen IS, Wang HY, Chen CY, Tseng KC, et al. Ledipasvir/Sofosbuvir for 12 Weeks Is Safe and Effective in Patients With Chronic Hepatitis C and Hepatitis B Coinfection: a Phase 3 Study in Taiwan [Poster SAT-243]. EASL: The International Liver Congress; 2019 10-14 April; Vienna, Austria.
- Liu CJ, Chuang WL, Sheen IS, Wang HY, Chen CY, Tseng KC, et al. Declines in HBsAg Levels Observed During Treatment With Ledispavir/Sofosbuvir in Patients With Chronic Hepatitis B Virus and Hepatitis C Virus Infection [Poster 1083]. The Liver Meeting® 2017 - The 68th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD); 2017 20-24 October; Washington, D. C.
- Liu CJ, Chuang WL, Sheen IS, Wang HY, Chen CY, Tseng KC, Chang TT, Massetto B, Yang JC, Yun C, Knox SJ, Osinusi A, Camus G, Jiang D, Brainard DM, McHutchison JG, Hu TH, Hsu YC, Lo GH, Chu CJ, Chen JJ, Peng CY, Chien RN, Chen PJ. Efficacy of Ledipasvir and Sofosbuvir Treatment of HCV Infection in Patients Coinfected With HBV. Gastroenterology. 2018 Mar;154(4):989-997. doi: 10.1053/j.gastro.2017.11.011. Epub 2017 Nov 22.
- Liu CJ, Chuang WL, Sheen IS, Wang HY, Chen CY, Tseng KC, et al. Ledipasvir/Sofosbuvir for 12 Weeks Is Safe and Effective in Patients with Chronic Hepatitis C and Hepatitis B Coinfection: A Phase 3 Study in Taiwan [Presentation]. The International Liver Congress™ 2017: European Association for the Study of the Liver (EASL); 2017 19-23 April; Amsterdam, the Netherlands.
- Liu CJ, Sheen IS, Chen CY, Chuang WL, Wang HY, Tseng KC, Chang TT, Yang J, Massetto B, Suri V, Camus G, Jiang D, Zhang F, Gaggar A, Hu TH, Hsu YC, Lo GH, Chu CJ, Chen JJ, Peng CY, Chien RN, Chen PJ. Ledipasvir/Sofosbuvir for Patients Coinfected With Chronic Hepatitis C and Hepatitis B in Taiwan: Follow-up at 108 Weeks Posttreatment. Clin Infect Dis. 2022 Aug 31;75(3):453-459. doi: 10.1093/cid/ciab971.
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Sygdomme i fordøjelsessystemet
- RNA-virusinfektioner
- Virussygdomme
- Infektioner
- Blodbårne infektioner
- Overførbare sygdomme
- Leversygdomme
- Flaviviridae infektioner
- Hepatitis, viral, menneskelig
- Enterovirus infektioner
- Picornaviridae infektioner
- Hepatitis
- Hepatitis A
- Hepatitis C
- Co-infektion
- Anti-infektionsmidler
- Antivirale midler
- Sofosbuvir
- Ledipasvir, sofosbuvir lægemiddelkombination
- Ledipasvir
Andre undersøgelses-id-numre
- GS-US-337-1655
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
IPD-delingstidsramme
IPD-delingsadgangskriterier
IPD-deling Understøttende informationstype
- Studieprotokol
- Statistisk analyseplan (SAP)
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
produkt fremstillet i og eksporteret fra U.S.A.
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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