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Impact of Hepatitis C Therapy and Bone Health (HCV)

15 août 2019 mis à jour par: Dallas VA Medical Center

Impact of HCV Therapy on Cardiovascular Risk and Bone Health

An evaluation of the impact of Elbasvir and Grazoprevir (EBR/GZR) HCV therapy on the heart risk and bone health of HCV mono-infected and HIV/HCV co-infected patients.

Aperçu de l'étude

Statut

Résilié

Les conditions

Intervention / Traitement

Description détaillée

Both HCV and HIV are associated with an increased risk of osteoporosis and osteoporotic fractures among HIV-infected patients and the general population. While HIV significantly increases cardiovascular risk, the contribution of HCV to cardiovascular disease (CVD) is less certain. Increased inflammation could potentially underlie the effect of HCV on CVD, bone health, and other extra-hepatic complications. HCV appears to remain an independent predictor of osteoporotic fractures even after controlling for severity of liver disease. The impact of HCV therapy on inflammation, CVD and bone health is unclear. Our previous studies suggest a beneficial impact of interferon therapy on bone turnover and some CVD markers, while others studies have found on-treatment increases in bone mineral density with interferon-based therapy. Whether these are related to the interferon itself or the virologic response, and whether changes in biomarkers lead to improved fracture risk or CVD morbidity is uncertain. Investigator propose to conduct a prospective analysis of markers of inflammation, immune activation, and bone turnover as well as bone mineral density (BMD) among both HIV/HCV co-infected and HCV mono-infected patients undergoing treatment with the novel direct-acting antiviral elbasvir/grazoprevir (EBR/GZR). Should EBR/GZR therapy significantly improve CV risk and bone health, it would be an additional benefit and indication for its use in HCV therapy.

Type d'étude

Interventionnel

Inscription (Réel)

6

Phase

  • Phase 4

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • États-Unis
    • Texas
      • Dallas, Texas, États-Unis, 75216
        • Dallas VA Medical Center

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

40 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Homme

La description

Inclusion Criteria:

  1. HCV antibody and HCV RNA positive
  2. HCV Genotype 1a, 1b, or 4

  3. 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

  4. 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:

    1. raltegravir
    2. dolutegravir
    3. 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:

  1. Hepatitis B surface antigen positivity
  2. Decompensated cirrhosis (Child Pugh B or C)
  3. Any prior hepatitis C treatment
  4. Pregnant or nursing
  5. Treatment with any medication specifically contraindicated with EBR/GZR or not recommended for concomitant use as per the prescribing label (Table 2)
  6. Age less than 18
  7. Prisoners or subjects otherwise involuntarily incarcerated
  8. Absence of signed informed consent by patient or appropriate surrogate
  9. Known hypersensitivity to elbasvir or grazoprevir
  10. For patients with genotype 1a, one more of the following mutations on baseline NS5A genotype: M28, Q30, L31, or Y93

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Non randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: EBR/GZR (Zepatier) - HCV/HIV co-infected
Drug: Elbasvir (EBR) 50 mg and Grazoprevir (GZR) 100 mg single tablet by mouth, once daily.
Médicament: EBR/GZR
Elbasvir and Grazoprevir (EBR/GZR) tablet by mouth, once daily.
Autres noms:
  • Zépatier
Expérimental: EBR/GZR (Zepatier) - HCV monoinfected
Drug: Elbasvir (EBR) 50 mg and Grazoprevir (GZR) 100 mg single tablet by mouth, once daily.
Médicament: EBR/GZR
Elbasvir and Grazoprevir (EBR/GZR) tablet by mouth, once daily.
Autres noms:
  • Zépatier

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
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
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Impact of EBR/GZR HCV therapy on the cardiovascular risk and bone health of HCV mono-infected patients.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Dallas VA Medical Center

Collaborateurs

Merck Sharp & Dohme LLC

Les enquêteurs

  • Chercheur principal: Roger Bedimo, MD, Dallas VAMC

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

28 août 2017

Achèvement primaire (Réel)

26 novembre 2018

Achèvement de l'étude (Réel)

30 novembre 2018

Dates d'inscription aux études

Première soumission

27 juin 2017

Première soumission répondant aux critères de contrôle qualité

13 juillet 2017

Première publication (Réel)

18 juillet 2017

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

19 août 2019

Dernière mise à jour soumise répondant aux critères de contrôle qualité

15 août 2019

Dernière vérification

1 août 2019

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • MISP 54850

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

Non

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Oui

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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