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

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

Status
Unknown
Phases
Unknown
Study type
Interventional
Source
REPEC
Registry ID
PER-058-12
Enrollment
9
Registered
2012-08-20
Start date
Unknown
Completion date
Unknown
Last updated
2023-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

IT IS DESIGNED TO EVALUATE THE LONG-TERM TOLERABILITY AND SAFETY OF BOSENTAN USING THE PEDIATRIC FORMULATION IN CHILDREN WITH IDIOPATHIC OR HERITABLE PAH OR PAH PERSISTING AFTER COMPLETE REPAIR OF A C

Sponsors

Actelion Pharmaceuticals Ltd,
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 19 Years

Inclusion criteria

Inclusion criteria: 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) OR 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.

Exclusion criteria

Exclusion criteria: 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.

Outcome results

None listed

Source: REPEC (via WHO ICTRP)