- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT03221582
Impact of Hepatitis C Therapy and Bone Health (HCV)
Impact of HCV Therapy on Cardiovascular Risk and Bone Health
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 4
Contacten en locaties
Studie Locaties
-
-
Texas
-
Dallas, Texas, Verenigde Staten, 75216
- Dallas VA Medical Center
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- HCV antibody and HCV RNA positive
- HCV Genotype 1a, 1b, or 4
Liver staging assessment:
a. Cirrhosis will be defined by any of the following: i. A liver biopsy prior to day 1 of this study showing cirrhosis (F4) ii. Fibroscan within 12 calendar months of day 1 of this study showing cirrhosis with result > 12.5 kPa iii. FibroSURE performed during screening with a score > 0.75 and APRI > 2 b. Absence of cirrhosis will be defined by any of the following: i. Liver biopsy performed within 24 months of day 1 of this study showing absence of cirrhosis ii. Fibroscan performed within 12 months of day 1 of this study with a result of ≤ 12.5 kPa iii. FibroSURE score ≤ 0.48 and APRI ≤ 1 during screening
If HIV co-infected, HAART regimen will consist of two NRTIs (abacavir, tenofovir disoproxil fumarate or tenofovir alafenamide, each in combination with lamivudine or emtricitabine) with one of the following 3rd agents:
- raltegravir
- dolutegravir
- rilpivirine HIV co-infected patients must be on their stable HAART regimen for at least 6 months, with HIV viral load < 50 c/mL at screening
Exclusion Criteria:
- Hepatitis B surface antigen positivity
- Decompensated cirrhosis (Child Pugh B or C)
- Any prior hepatitis C treatment
- Pregnant or nursing
- Treatment with any medication specifically contraindicated with EBR/GZR or not recommended for concomitant use as per the prescribing label (Table 2)
- Age less than 18
- Prisoners or subjects otherwise involuntarily incarcerated
- Absence of signed informed consent by patient or appropriate surrogate
- Known hypersensitivity to elbasvir or grazoprevir
- For patients with genotype 1a, one more of the following mutations on baseline NS5A genotype: M28, Q30, L31, or Y93
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Niet-gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Experimenteel: EBR/GZR (Zepatier) - HCV/HIV co-infected
Drug: Elbasvir (EBR) 50 mg and Grazoprevir (GZR) 100 mg single tablet by mouth, once daily.
|
Elbasvir and Grazoprevir (EBR/GZR) tablet by mouth, once daily.
Andere namen:
|
Experimenteel: EBR/GZR (Zepatier) - HCV monoinfected
Drug: Elbasvir (EBR) 50 mg and Grazoprevir (GZR) 100 mg single tablet by mouth, once daily.
|
Elbasvir and Grazoprevir (EBR/GZR) tablet by mouth, once daily.
Andere namen:
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Evaluate the impact of EBR/GZR HCV therapy on the cardiovascular risk and bone health of HCV mono-infected patients and HIV/HCV co-infected patients
Tijdsspanne: 48 weeks
|
Cardiovascular health will be assessed by serologic markers of inflammation; in addition to, positron emission tomography (PET) scanning for arterial inflammation, coronary calcification and myocardial viability.
|
48 weeks
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Impact of EBR/GZR HCV therapy on the cardiovascular risk and bone health of HCV mono-infected patients.
Tijdsspanne: Biomarkers of inflammation and bone turnover measured at week 0 of therapy.
|
Cardiovascular health will be assessed by serologic markers of inflammation; in addition to, PET scanning for arterial inflammation, coronary calcification and myocardial viability.
Bone health will be assessed by serological markers of bone turnover and bone mineral density (BMD) by dual energy x-ray absorptiometry (DXA) scan and trabecular bone score (TBS).
|
Biomarkers of inflammation and bone turnover measured at week 0 of therapy.
|
Impact of EBR/GZR HCV therapy on the cardiovascular risk and bone health of HCV mono-infected patients.
Tijdsspanne: Bone mineral density measured at week 0 of therapy
|
Cardiovascular health will be assessed by serologic markers of inflammation; in addition to, PET scanning for arterial inflammation, coronary calcification and myocardial viability.
Bone health will be assessed by serological markers of bone turnover and bone mineral density (BMD) by DXA scan and trabecular bone score (TBS).
|
Bone mineral density measured at week 0 of therapy
|
Impact of EBR/GZR HCV therapy on the cardiovascular risk and bone health of HCV mono-infected patients.
Tijdsspanne: Biomarkers of inflammation and bone turnover measured at week 12 of therapy.
|
Cardiovascular health will be assessed by serologic markers of inflammation; in addition to, PET scanning for arterial inflammation, coronary calcification and myocardial viability.
Bone health will be assessed by serological markers of bone turnover and bone mineral density (BMD) by DXA scan and trabecular bone score (TBS).
|
Biomarkers of inflammation and bone turnover measured at week 12 of therapy.
|
Impact of EBR/GZR HCV therapy on the cardiovascular risk and bone health of HCV mono-infected patients.
Tijdsspanne: Biomarkers of inflammation and bone turnover measured at week 24 of therapy.
|
Cardiovascular health will be assessed by serologic markers of inflammation; in addition to, PET scanning for arterial inflammation, coronary calcification and myocardial viability.
Bone health will be assessed by serological markers of bone turnover and bone mineral density (BMD) by DXA scan and trabecular bone score (TBS).
|
Biomarkers of inflammation and bone turnover measured at week 24 of therapy.
|
Impact of EBR/GZR HCV therapy on the cardiovascular risk and bone health of HCV mono-infected patients.
Tijdsspanne: Bone mineral density measured at week 48 of therapy.
|
Cardiovascular health will be assessed by serologic markers of inflammation; in addition to, PET scanning for arterial inflammation, coronary calcification and myocardial viability.
Bone health will be assessed by serological markers of bone turnover and bone mineral density (BMD) by DXA scan and trabecular bone score (TBS).
|
Bone mineral density measured at week 48 of therapy.
|
Impact of EBR/GZR HCV therapy on the cardiovascular risk and bone health of HIV/HCV co-infected patients.
Tijdsspanne: Biomarkers of inflammation and bone turnover measured at week 0 of therapy.
|
Cardiovascular health will be assessed by serologic markers of inflammation; in addition to, PET scanning for arterial inflammation, coronary calcification and myocardial viability.
Bone health will be assessed by serological markers of bone turnover and bone mineral density (BMD) by DXA scan and trabecular bone score (TBS).
|
Biomarkers of inflammation and bone turnover measured at week 0 of therapy.
|
Impact of EBR/GZR HCV therapy on the cardiovascular risk and bone health of HIV/HCV co-infected patients.
Tijdsspanne: Bone mineral density measured at week 0 of therapy
|
Cardiovascular health will be assessed by serologic markers of inflammation; in addition to, PET scanning for arterial inflammation, coronary calcification and myocardial viability.
Bone health will be assessed by serological markers of bone turnover and bone mineral density (BMD) by DXA scan and trabecular bone score (TBS).
|
Bone mineral density measured at week 0 of therapy
|
Impact of EBR/GZR HCV therapy on the cardiovascular risk and bone health of HIV/HCV co-infected patients.
Tijdsspanne: Biomarkers of inflammation and bone turnover measured at week 12 of therapy.
|
Cardiovascular health will be assessed by serologic markers of inflammation; in addition to, PET scanning for arterial inflammation, coronary calcification and myocardial viability.
Bone health will be assessed by serological markers of bone turnover and bone mineral density (BMD) by DXA scan and trabecular bone score (TBS).
|
Biomarkers of inflammation and bone turnover measured at week 12 of therapy.
|
Impact of EBR/GZR HCV therapy on the cardiovascular risk and bone health of HIV/HCV co-infected patients.
Tijdsspanne: Biomarkers of inflammation and bone turnover measured at week 24 of therapy.
|
Cardiovascular health will be assessed by serologic markers of inflammation; in addition to, PET scanning for arterial inflammation, coronary calcification and myocardial viability.
Bone health will be assessed by serological markers of bone turnover and bone mineral density (BMD) by DXA scan and trabecular bone score (TBS).
|
Biomarkers of inflammation and bone turnover measured at week 24 of therapy.
|
Impact of EBR/GZR HCV therapy on the cardiovascular risk and bone health of HIV/HCV co-infected patients.
Tijdsspanne: Biomarkers of inflammation and bone turnover measured at week 48 of therapy.
|
Cardiovascular health will be assessed by serologic markers of inflammation; in addition to, PET scanning for arterial inflammation, coronary calcification and myocardial viability.
Bone health will be assessed by serological markers of bone turnover and bone mineral density (BMD) by DXA scan and trabecular bone score (TBS).
|
Biomarkers of inflammation and bone turnover measured at week 48 of therapy.
|
Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Roger Bedimo, MD, Dallas VAMC
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- Ziekten van het spijsverteringsstelsel
- RNA-virusinfecties
- Virusziekten
- Infecties
- Door bloed overgedragen infecties
- Overdraagbare ziekten
- Seksueel overdraagbare aandoeningen, viraal
- Seksueel overdraagbare aandoeningen
- Lentivirus-infecties
- Retroviridae-infecties
- Immunologische deficiëntie syndromen
- Ziekten van het immuunsysteem
- Lever Ziekten
- Flaviviridae-infecties
- Hepatitis, viraal, menselijk
- Enterovirusinfecties
- Picornaviridae-infecties
- Langzame virusziekten
- HIV-infecties
- Hepatitis
- Hepatitis A
- Hepatitis C
- Verworven Immunodeficiëntie Syndroom
- Anti-infectieuze middelen
- Antivirale middelen
- Elbasvir-grazoprevir geneesmiddelcombinatie
Andere studie-ID-nummers
- MISP 54850
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
Klinische onderzoeken op Hepatitis C
-
Tripep ABInovio PharmaceuticalsOnbekendChronische hepatitis C-virusinfectieZweden
-
Hadassah Medical OrganizationXTL BiopharmaceuticalsIngetrokkenChronische hepatitis C-virusinfectieIsraël
-
Hadassah Medical OrganizationOnbekendChronische hepatitis C-virusinfectieIsraël
-
Trek Therapeutics, PBCVoltooidChronische Hepatitis C | Hepatitis C Genotype 1 | Hepatitis C (HCV) | Hepatitis C virale infectieVerenigde Staten, Nieuw-Zeeland
-
Trek Therapeutics, PBCVoltooidChronische Hepatitis C | Hepatitis C (HCV) | Hepatitis C Genotype 4 | Hepatitis C virale infectieVerenigde Staten
-
AbbVieVoltooidHepatitis C-virus | Chronisch hepatitis C-virus
-
Beni-Suef UniversityVoltooidChronische hepatitis C-virusinfectieEgypte
-
AbbVieVoltooidChronische Hepatitis C | Hepatitis C (HCV) | Hepatitis C Genotype 1a
-
University Health Network, TorontoVoltooidChronische hepatitis C-infectieCanada
-
AbbVie (prior sponsor, Abbott)VoltooidChronische Hepatitis C | Hepatitis C Genotype 1 | Hepatitis C (HCV)Verenigde Staten, Australië, Canada, Frankrijk, Duitsland, Nieuw-Zeeland, Puerto Rico, Spanje, Verenigd Koninkrijk
Klinische onderzoeken op EBR/GZR
-
National Taiwan University HospitalMerck Sharp & Dohme LLCVoltooid
-
Merck Sharp & Dohme LLCVoltooid
-
Merck Sharp & Dohme LLCVoltooid
-
Merck Sharp & Dohme LLCVoltooidHCV-infectieVerenigde Staten, Duitsland, Polen, Zweden
-
Ontario Clinical Oncology Group (OCOG)Canadian Cancer Society (CCS)VoltooidNiet-kleincellige longkankerCanada
-
Gan and Lee Pharmaceuticals, USAVoltooidDiabetes mellitus, type 2Verenigde Staten
-
University of FloridaPatient-Centered Outcomes Research Institute; Merck Sharp & Dohme LLC; AbbVieVoltooidChronische Hepatitis CVerenigde Staten
-
Lipomedix Pharmaceuticals Inc.VoltooidKanker | Vaste tumor | Metastatische ziekteIsraël
-
Valme University HospitalHospital General Universitario Elche; Hospital del SAS de Jerez; Clinica Universidad... en andere medewerkersVoltooidChronische hepatitis C-infectieSpanje