10mg macitentan tablets, taken once daily (QD), by mouth (PO), for the treatment period lasting 16 weeks.

Pulmonary Hypertension

Sickle Cell Disease

macitentan

Boston University School of Medicine

Macitentan in Pulmonary Hypertension of Sickle Cell Disease

The Safety and Efficacy of Macitentan for Treatment of Pulmonary Hypertension in Sickle Cell Disease

Assess the rate of adverse and serious adverse events in SCD patients taking macitentan

Assess the change in the following hemodynamic parameters, by right heart catheterization, from baseline after 16 weeks of 10 mg daily of macitentan:
Right atrial pressure (RAP) Right ventricular pressure (RVP) Systolic pulmonary artery pressure (SPAP) Diastolic pulmonary artery pressure (PADP)

Assess the change in the following hemodynamic parameters, by right heart catheterization, from baseline after 16 weeks of 10 mg daily of macitentan:
Cardiac output (CO)

Assess the change in the following hemodynamic parameters, by right heart catheterization, from baseline after 16 weeks of 10 mg daily of macitentan:
Cardiac index (CI)

Assess the change in the following hemodynamic parameters, by right heart catheterization, from baseline after 16 weeks of 10 mg daily of macitentan:
Systemic vascular resistance (SVR) Right ventricular function assessed by pressure-volume loop measurements

Assess the change in the following hemodynamic parameters, by right heart catheterization, from baseline after 16 weeks of 10 mg daily of macitentan:
Right ventricular function assessed by pressure-volume loop measurements

Assess the change from baseline in 6MWT after 16 weeks of 10 mg daily macitentan

Assess the change from baseline of Borg Dyspnea Index (BDI) after 16 weeks of 10 mg daily macitentan

Assess the change from baseline in NYHA/WHO functional classification after 16 weeks of 10 mg daily macitentan

Assess the change from baseline in cardiac biomarkers (e.g., BNP, NT-pro-BNP) after 16 weeks of 10 mg daily macitentan

Boston University

Actelion

Intensive care support and Equine F(ab')2 antivenom

Poisoning by Scorpion Sting

A single dose of 4 vials of Equine F(ab')2 antivenom will be administered intravenously over 10 minute

Equine F(ab')2 antivenom

Intensive care support as needed plus placebo

Intensive care support plus placebo

CHU Hassan II de Fès

Hôpital Ibn Zohr, Marrakech

A Trial of Equine F (ab')2 Antivenom for Treatment of Scorpion Envenomation in Morocco

Phase 2/3 Study for Scorpion North Africa Middle East Envenomation With a Immune F(ab')2 (Equine) Antivenom Alacramyn NAMO. A Randomized, Double-Blind, Placebo-controlled, Prospective and Multicenter Study

Comparison between antivenom and placebo groups of the number of cases showing improvement in class of envenomation.

Decrease in plasma venom levels from baseline to one hour after study drug administration; Respiratory rate (breaths per minute); Heart rate (beats per minute); Dose of dobutamine (cumulative, per hour);Incidence of cardiac failure; Incidence of ventilatory failure; Incidence of neurological failure; Mortality

Instituto Bioclon S.A. de C.V.

Centre Antipoison et de Pharmacovigilane du Maroc

Institut Pasteur du Maroc

a clinical scoring system for dose requirement for AScVS is evolved based on sweating, pulse rate, respiratory rate, blood pressure, CNS effects and presence of priapism. Computed doses were given according to clinical grading as intravenous bolus slowly.

Prazosin therapy Prazosin (30 micrograms/Kg/dose): 500 micrograms for pediatric patient, and 1mg for adult patients) will be given every 3 hourly orally till complete recovery.

Combination AScVS and Prazosin therapy In this group, AScVS therapy will be given as mentioned in AScVS therapy group and in addition, prazosin (500 micrograms for pediatric patient and 1mg for adult patients,30 micrograms/Kg/dose) every 3 hourly will be given.

Scorpion Envenomation

AScVS therapy group
If the score is 5 and if the patient belongs to pediatric group(>12-14): 1 vial AScVS as i.v. slow bolus after test dose If the score is 5 and if the patient is adult: 2 vials of AScVS as i.v. slow bolus after test dose. For injection, 1 vial will be dissolved in 10 ml distilled water and given over a period of 4 to 5 minutes.
According to the scores 1 vial for pediatric and 2 vials for adult patient will be increased as shown below:
Vials of AScVS Composite score Child Adult 5-10 2 4 > 10-15 3 6 >15- 21 4 8

Antiscorpion venom serum(AScVS).

T.Prazosin

Combination AScVS and Prazosin therapy In this group, AScVS therapy will be given as mentioned in AScVS therapy group and in addition, prazosin(500 micrograms for pediatric patient and 1mg for adult patients,30 micrograms/Kg/dose) every 3 hourly will be given.

AScVS + Prazosin

Kushte Hospital

Natu Hospital

Sane Hospital

Mangaon cottage hospital, Mangaon.

Vijayshree Hospital,At & Po.Umroli,Tal. Chiplun.

AScVS and/ or Prazosin for Scorpion Envenomation

Comparative Study of Efficacy of Antiscorpion Venom Serum(AScVS)vs Prazosin in the Management of Severe Scorpion(Mesobuthus Tamulus Concanesis Pocock)Envenomation and Evaluation of Effects of the Combination of AScVS + Prazosin Therapy.

priapism/edema

Macitentan in Pulmonary Hypertension of Sickle Cell Disease

A Trial of Equine F (ab')2 Antivenom for Treatment of Scorpion Envenomation in Morocco

AScVS and/ or Prazosin for Scorpion Envenomation

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