Tip 1 Gaucher Hastalarında GA-GCB Enzim Replasman Tedavisinin Açık Etiketli Uzatma Çalışması

Sade dilde özet

Bu çalışma, Tip 1 Gaucher Hastalığı (Gaucher disease) olan hastalarda GA-GCB (VPRIV) enzim replasman tedavisinin uzun dönem uygulamasını (açık etiketli uzatma) inceliyor. Önceki GA-GCB çalışmalarını tamamlamış hastalar dahil edilmiştir. Faz 3 aşamasında yürütülmüş ve tamamlanmıştır.

Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.

Deney bilgileri

Faz

Faz 3 (Phase 3)

Durum

Tamamlandı

Sponsor

Shire

Müdahale

VPRIV®

Başlangıç

13.03.2008

Tahmini bitiş

28.12.2012

Ülkeler

United States, Argentina, India, Israel, Paraguay, Poland, Russia, South Korea, Spain, Tunisia, United Kingdom

İlgili genler

Merkezler

• Los Angeles, United States
• Oakland, United States
• Atlanta, United States
• Chicago, United States
• Minneapolis, United States
• Kansas City, United States
• New York, United States
• Cincinnati, United States
• Salt Lake City, United States
• Milwaukee, United States
• Buenos Aires, Argentina
• New Delhi, India
• Pune, India
• Jerusalem, Israel
• Asunción, Paraguay
• Warsaw, Poland
• Moscow, Russia
• Jinju, South Korea
• Zaragoza, Spain
• Tunis, Tunisia
• London, United Kingdom

Uygunluk kriterleri

Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.

Inclusion Criteria:

1. The patient has completed study TKT032 or TKT034, or study HGT-GCB-039.
2. Female patients of child-bearing potential must agree to use a medically acceptable method of contraception at all times during the study and must have negative results to a pregnancy test performed at the time of enrollment and as required throughout their participation in the study.
3. Male patients must agree to use a medically acceptable method of contraception at all times during the study and report a partner's pregnancy to the investigator.
4. The patient, the patient's parent(s) or legal guardian(s) has provided written informed consent that has been approved by the Institutional Review Board/Independent Ethics Committee (IRB/IEC).
5. The patient must be sufficiently cooperative to participate in this clinical study as judged by the Investigator

Exclusion Criteria:

1. The patient has received treatment with any non-Gaucher disease-related investigational drug or device within the 30 days prior to study entry; such use during the study is not permitted.
2. The patient is pregnant or lactating.
3. The patient, patient's parent(s), or patient's legal guardian(s) is/are unable to understand the nature, scope, and possible consequences of the study.
4. The patient has a significant comorbidity(ies) that might affect study data or confound the study results (e.g., malignancies, primary biliary cirrhosis, autoimmune liver disease, etc.).
5. The patient is unable to comply with the protocol, e.g., has a clinically relevant medical condition making implementation of the protocol difficult, has an uncooperative attitude, is unable to return for safety evaluations, or is otherwise unlikely to complete the study, as determined by the Investigator