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1.
Indian J Hematol Blood Transfus ; 39(4): 630-634, 2023 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-37790744

RESUMO

Purpose: Hemophilia B is an X-linked congenital bleeding disorder caused by a deficiency of coagulation factor IX (FIX) clotting activity. This study evaluated safety and efficacy of nonacog alfa, a recombinant human blood coagulation FIX replacement product, in males aged 12-65 years with hemophilia B (FIX activity ≤ 2%) with or without inhibitors in India. Methods: In this multicenter, open-label, post-approval phase 4 study, participants were treated for up to 8 weeks, with up to a 4-week screening period and a subsequent post-treatment 28-day safety observation period. Intravenous nonacog alfa 40 IU/kg (range 13-78 IU/kg) was administered at intervals of 3-4 days, in accordance with the approved local product document. Results: A total of 25 participants were enrolled and completed the study. No participants developed FIX inhibitors during the study, experienced treatment-related adverse events (AEs) or serious AEs, or developed a thrombotic event and/or hypersensitivity reaction. No participants experienced bleeding events requiring on-demand treatment with nonacog alfa. Seventeen bleeding episodes (16 spontaneous and 1 traumatic) were reported in 10 participants; all occurred post treatment, with the exception of a minor gum-bleeding event, and were managed without treatment. The mean (SD) annualized total factor consumption (TFC) per patient was 224,582 (75,527) IU; the mean (SD) annualized TFC by weight per patient was 3639 (573) IU/kg. Conclusion: Nonacog alfa was safe and effective for the prevention of hemorrhagic episodes in Indian males with congenital, severe hemophilia B. No participants developed FIX inhibitors, and no new safety signals were reported.

2.
Indian J Hematol Blood Transfus ; : 1-6, 2022 Nov 27.
Artigo em Inglês | MEDLINE | ID: mdl-36467512

RESUMO

Purpose: Hemophilia A is an X-linked congenital disorder, characterized by factor VIII (FVIII) deficiency. Globally, India has the highest population of patients with hemophilia, and there is a clear unmet need for appropriate and effective treatment for this patient population. This multicenter, open-label, post-approval study evaluated the safety and efficacy of moroctocog alfa in patients with moderate or severe congenital hemophilia A in India. Methods: Intravenous moroctocog alfa was administered 30 ± 5 IU/kg 3 times weekly for bleeding prophylaxis, according to the local product document. Participants were treated for up to 8 weeks, with an up to 4-week screening period and a subsequent post-treatment, 28-day safety observation period. Patients continued in the study until at least 24 exposure days or a period of up to 8 weeks on moroctocog alfa. Results: A total of 50 participants were enrolled, and 48 (85.7%) completed the study. No participants developed FVIII inhibitors during the study. The mean (SD) annualized bleeding rate during moroctocog alfa prophylaxis was 0.79 (2.0) with a median (range) of 0.00 (0.0, 6.8). The mean (SD) annualized total factor consumption (TFC) per participant was 287,432 (93,866) IU; the mean (SD) annualized TFC by weight per participant was 4176 (858) IU/kg. Moroctocog alfa was well tolerated with no reported treatment-emergent adverse event-related dose reductions, discontinuations, or serious adverse events. Conclusion: Moroctocog alfa was safe, effective, and well tolerated in Indian participants with congenital moderate to severe hemophilia A. No participant developed FVIII inhibitors during the study.

3.
Perspect Clin Res ; 11(3): 115-120, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-33033700

RESUMO

The COVID-19 pandemic may impact the conduct of clinical trials of medical products. Challenges have arisen, from country/ state lockdowns, site closures due to hospitals being taken over / sites being taken over for COVID-19 related care, travel limitations to sites for patients, interruptions to the supply chain for the investigational product, or other considerations if site personnel or trial subjects become infected with COVID-19. These challenges may lead to difficulties in meeting protocol-specified procedures, including administering or using the investigational product or adhering to protocol-scheduled visits and laboratory/diagnostic testing. This position paper from the perspective of Indian Society for Clinical Research (ISCR) aims to provide guidance to both frontline Clinical Research Professionals and sponsors on measures that can be taken while continuing ongoing clinical trial activities at site as well as resuming site level activities in the post COVID setting. Broad guidance is also given to sites and sponsors on use of Direct to Patient drug shipments, supplies and cold chain management and use of technologies to support enhanced remote functioning during and post COVID.

4.
Orthop Clin North Am ; 35(1): 1-5, 2004 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-15062712

RESUMO

Although it is clear that LBP imposes a grave economic cost on society, the lack of consensus on causes and appropriate treatments makes it difficult to develop explicit guidelines and best practices. To gain a greater understanding of the economic impact of the condition and to reduce the unnecessary procedures that patients undergo, a series of cost-effectiveness analyses on established treatment options and on proposed integrated programs of prevention, treatment, and counseling, would be not only informative but integral to the progress of LBP disease management.


Assuntos
Dor Lombar/economia , Efeitos Psicossociais da Doença , Análise Custo-Benefício , Gerenciamento Clínico , Humanos , Dor Lombar/psicologia , Dor Lombar/terapia , Estados Unidos
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