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  • Ovid Technologies (Wolters Kluwer Health)  (5)
  • 1
    Online Resource
    Online Resource
    Relation Between HIV-1 and Hepatitis C Viral Load in Patients With Hemophilia
    Ovid Technologies (Wolters Kluwer Health) ; 2001
    In:  Journal of Acquired Immune Deficiency Syndromes Vol. 26, No. 5 ( 2001-04), p. 466-472
    Details
    In: Journal of Acquired Immune Deficiency Syndromes, Ovid Technologies (Wolters Kluwer Health), Vol. 26, No. 5 ( 2001-04), p. 466-472
    Type of Medium: Online Resource
    ISSN: 1525-4135
    URL: Article
    DOI: 10.1097/00042560-200104150-00011
    RVK:
    XA 10000
    RVK:
    XA 51942
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2001
    detail.hit.zdb_id: 2038673-4
    Location Call Number Limitation Availability
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  • 2
    Online Resource
    Online Resource
    Evaluation of biomarkers for monitoring thrombogenic potential of FXaI16L
    Ovid Technologies (Wolters Kluwer Health) ; 2020
    In:  Blood Coagulation & Fibrinolysis Vol. 31, No. 1 ( 2020-01), p. 16-28
    Details
    In: Blood Coagulation & Fibrinolysis, Ovid Technologies (Wolters Kluwer Health), Vol. 31, No. 1 ( 2020-01), p. 16-28
    Abstract: A zymogen-like activated factor X variant (FXa I16L ) is being developed for treating acute bleeding conditions. Activated factor V is an essential cofactor to FXa I16L for activating prothrombin to thrombin. Thrombi/emboli formation was observed microscopically in FXa I16L toxicity studies in animals. The objective of this research was to evaluate candidate biomarkers for FXa I16L -induced thrombi/emboli formation to inform safety monitoring and dose-escalation decisions in FXa I16L clinical trials. Effects of intravenous FXa I16L administration on platelets, fibrinogen, activated partial thromboplastin time (aPTT), prothrombin time (PT), d -dimer, tissue factor pathway inhibitor, thrombin : antithrombin complex, antithrombin, and factor V, and protein C (PC) activities were evaluated in mice, rats, and monkeys. Mice had endogenous factor V activity 10× that of monkeys and were overly sensitive to FXa I16L -induced thrombi/emboli formation. In monkeys, decreases in fibrinogen and prolongation in aPTT and PT emerged as potential biomarkers for impending FXa I16L -induced thrombi/emboli formation, based on association of changes with microscopically observable thrombi/emboli (0–97 thrombi/emboli per monkey). PC decreases, measured by a clot-based assay, were also observed. A similar reduction in PC activity, when measured by clot-based assay, was observed in a phase 1 clinical trial. However, an in-vitro experiment with human plasma spiked with increasing concentrations of FXa I16L indicated dose-dependent FXa I16L -induced interference with clot-based assays and no depletion of PC or S by FXa I16L in non-clot-based assays. Nonclinical biomarker studies identified fibrinogen, aPTT and PT as potential biomarkers for monitoring the clinical safety of FXa I16L . Results of clot-based assays with FXa I16L treatment should be interpreted with caution.
    Type of Medium: Online Resource
    ISSN: 0957-5235 , 1473-5733
    URL: Article
    DOI: 10.1097/MBC.0000000000000866
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2020
    detail.hit.zdb_id: 2035229-3
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  • 3
    Online Resource
    Online Resource
    Phase 1b Study to Evaluate Safety, Tolerability, and Maximum Tolerated Dose of PF-05230907 for Intracerebral Hemorrhage
    Ovid Technologies (Wolters Kluwer Health) ; 2021
    In:  Stroke Vol. 52, No. 1 ( 2021-01), p. 294-298
    Details
    In: Stroke, Ovid Technologies (Wolters Kluwer Health), Vol. 52, No. 1 ( 2021-01), p. 294-298
    Abstract: This study aimed to determine the maximum tolerated dose and to evaluate the overall safety and tolerability of single doses of PF-05230907 in subjects with acute intracerebral hemorrhage. Methods: Individuals presenting with intracerebral hemorrhage were enrolled in a phase 1, multicenter, open-label clinical trial. A Bayesian modified continual reassessment method design based on treatment-emergent thromboembolic or ischemic events was adopted. Sequential dosing, an external data monitoring committee, and prespecified stopping rules were incorporated as safeguards. Results: Twenty-one subjects received PF-05230907. The mean (±SD) age in years and intracerebral hemorrhage volume in mL at baseline were 62 (±9) and 18 (±11), respectively. Two treatment-emergent thromboembolic or ischemic events occurred (deep vein thrombosis and cerebral ischemia), in the 30 μg/kg dose group. There were no other clear drug-related toxicities at dose levels ranging from 5 to 30 μg/kg. At the time of study termination, the maximum tolerated dose was estimated to be 24 μg/kg, with a mean fitted dose-toxicity estimate of 11.9% (95% CI, 1.2%–27.4%). Conclusions: Single doses of PF-05230907 appeared to be tolerated across a range of doses in the intracerebral hemorrhage population, with thrombotic events observed only at the highest dose level tested. Recruitment within the recommended therapeutic window of opportunity remains a challenge. Registration: URL: https://www.clinicaltrials.gov . Unique identifier: NCT02687191.
    Type of Medium: Online Resource
    ISSN: 0039-2499 , 1524-4628
    URL: Article
    DOI: 10.1161/STROKEAHA.120.029789
    RVK:
    XA 10000
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2021
    detail.hit.zdb_id: 1467823-8
    Location Call Number Limitation Availability
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    Online Resource
  • 4
    Online Resource
    Online Resource
    Relation Between HIV-1 and Hepatitis C Viral Load in Patients With Hemophilia
    Ovid Technologies (Wolters Kluwer Health) ; 2001
    In:  JAIDS Journal of Acquired Immune Deficiency Syndromes Vol. 26, No. 5 ( 2001-04), p. 466-472
    Details
    In: JAIDS Journal of Acquired Immune Deficiency Syndromes, Ovid Technologies (Wolters Kluwer Health), Vol. 26, No. 5 ( 2001-04), p. 466-472
    Type of Medium: Online Resource
    ISSN: 1525-4135
    URL: Article
    DOI: 10.1097/00126334-200104150-00011
    RVK:
    XA 10000
    RVK:
    XA 51942
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2001
    detail.hit.zdb_id: 2038673-4
    Location Call Number Limitation Availability
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    Online Resource
  • 5
    Online Resource
    Online Resource
    Bosutinib versus Placebo for Autosomal Dominant Polycystic Kidney Disease
    Ovid Technologies (Wolters Kluwer Health) ; 2017
    In:  Journal of the American Society of Nephrology Vol. 28, No. 11 ( 2017-11), p. 3404-3413
    Details
    In: Journal of the American Society of Nephrology, Ovid Technologies (Wolters Kluwer Health), Vol. 28, No. 11 ( 2017-11), p. 3404-3413
    Abstract: Overactivation of Src has been linked to the pathogenesis of autosomal dominant polycystic kidney disease (ADPKD). This phase 2, multisite study assessed the efficacy and safety of bosutinib, an oral dual Src/Bcr-Abl tyrosine kinase inhibitor, in patients with ADPKD. Patients with ADPKD, eGFR≥60 ml/min per 1.73 m 2 , and total kidney volume ≥750 ml were randomized 1:1:1 to bosutinib 200 mg/d, bosutinib 400 mg/d, or placebo for ≤24 months. The primary endpoint was annualized rate of kidney enlargement in patients treated for ≥2 weeks who had at least one postbaseline magnetic resonance imaging scan that was preceded by a 30-day washout (modified intent-to-treat population). Of 172 enrolled patients, 169 received at least one study dose. Per protocol amendment, doses for 24 patients who initially received bosutinib at 400 mg/d were later reduced to 200 mg/d. The annual rate of kidney enlargement was reduced by 66% for bosutinib 200 mg/d versus placebo (1.63% versus 4.74%, respectively; P =0.01) and by 82% for pooled bosutinib versus placebo (0.84% versus 4.74%, respectively; P 〈 0.001). Over the treatment period, patients receiving placebo or bosutinib had similar annualized eGFR decline. Gastrointestinal and liver-related adverse events were the most frequent toxicities. In conclusion, compared with placebo, bosutinib at 200 mg/d reduced kidney growth in patients with ADPKD. The overall gastrointestinal and liver toxicity profile was consistent with the profile in prior studies of bosutinib; no new toxicities were identified. (ClinicalTrials.gov: NCT01233869).
    Type of Medium: Online Resource
    ISSN: 1046-6673 , 1533-3450
    URL: Article
    DOI: 10.1681/ASN.2016111232
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2017
    detail.hit.zdb_id: 2029124-3
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