A PROSPECTIVE, MULTICENTER, NON-COMPARATIVE, OPEN LABEL EXTENSION OFTHE FUTURE 5 STUDY TO ASSESS SAFETY AND TOLERABILITY OF THE PEDIATRIC FORMULATION OF BOSENTAN IN CHILDREN WITH PULMONARY ARTERIAL HYPERTENSION.

Actelion Pharmaceuticals Ltd,0 个研究点目标入组 0 人开始时间: 2012年8月20日最近更新: 2023年9月4日

试验速览

暂无简介。

•1. SIGNED INFORMED CONSENT BY THE PARENTS/ LEGAL REPRESENTATIVES PRIOR TO ANY STUDY-MANDATED PROCEDURE.
•2. PATIENTS WHO:
•WERE TREATED FOR 12 WEEKS IN FUTURE 5 (AC--052--375)
•DISCONTINUED FUTURE 5 DUE TO PAH-PROGRESSION.
•AND WHO PERFORMED THE VISIT 5 ASSESSMENTS OF FUTURE 5 ACCORDING TO THE FUTURE 5 PROTOCOL.
•3. PATIENTS WHO DID NOT PREMATURELY DISCONTINUE THE STUDY DRUG DUE TO AES IN FUTURE 5
•4. FEMALES OF CHILDBEARING POTENTIAL MUST HAVE A NEGATIVE PRE-TREATMENT SERUM PREGNANCY TEST AND MUST USE RELIABLE METHODS OF CONTRACEPTION DURING THE WHOLE TREATMENT PERIOD AND FOR 1 MONTH AFTER STUDY DRUG DISCONTINUATION.
•RELIABLE METHODS OF CONTRACEPTION ARE:
•. BARRIER TYPE DEVICES (E.G., FEMALE CONDOM, DIAPHRAGM, CONTRACEPTIVE SPONGE) ONLY IN COMBINATION WITH A SPERMICIDE.
•. INTRA-UTERINE DEVICES.
•. ORAL, TRANSDERMAL, INJECTABLE OR IMPLANTABLE CONTRACEPTIVES ONLY IN COMBINATION WITH A BARRIER METHOD.
•HORMONE-BASED CONTRACEPTIVES ALONE, REGARDLESS OF THE ROUTE OF ADMINISTRATION, ARE NOT CONSIDERED AS RELIABLE METHODS OF CONTRACEPTION IN THIS CLINICAL STUDY. ABSTENTION, RHYTHM METHOD, AND CONTRACEPTION BY THE PARTNER ALONE ARE NOT ACCEPTABLE METHODS OF CONTRACEPTION IN THIS CLINICAL STUDY.

•1. KNOWN INTOLERANCE OR HYPERSENSITIVITY TO BOSENTAN OR ANY OF THE EXCIPIENTS OF THE BOSENTAN DISPERSIBLE TABLET.
•2. PREGNANCY OR BREASTFEEDING.
•3. ANY AST AND/OR ALT VALUES > 3 TIMES THE ULN UNTIL VISIT 5 OF FUTURE 5 (INCLUSIVE).
•4. MODERATE TO SEVERE HEPATIC IMPAIRMENT, I.E., CHILD-PUGH CLASS B OR C UNTIL VISIT 5 OF FUTURE 5 (INCLUSIVE).
•5. ANY CONDITION THAT PREVENTS COMPLIANCE WITH FUTURE 6 PROTOCOL OR ADHERENCE TO THERAPY.

发起方