Clinical Trials
8
Trial Phases
3 Phases
Drug Approvals
2
Drug Approvals
Trientine Hydrochloride Tablets
- Product Name
- 盐酸曲恩汀片
- Approval Number
- 国药准字HJ20230149
- Approval Date
- Dec 29, 2023
Clinical Trials
Distribution across different clinical trial phases (6 trials with phase data)• Click on a phase to view related trials
Patient Preference Study: Standard of Care Versus Once-daily Trientine Tetrahydrochloride
- Conditions
- Wilson's Disease
- Interventions
- Drug: New TETA 4HCl FormulationDrug: Standard of Care
- First Posted Date
- 2025-06-08
- Last Posted Date
- 2025-07-03
- Lead Sponsor
- Orphalan
- Target Recruit Count
- 10
- Registration Number
- NCT07010575
Study Comparing Once Daily Dose of 900mg of TETA 4HCL Against Cuprior® (450mg Trientine Base, Twice Daily).
- Conditions
- Wilson's Disease
- Interventions
- Drug: 900mg TETA 4HCl Once Daily FormulationDrug: 900mg TETA 4HCl Cuprior®
- First Posted Date
- 2023-11-13
- Last Posted Date
- 2024-06-25
- Lead Sponsor
- Orphalan
- Target Recruit Count
- 24
- Registration Number
- NCT06128954
- Locations
- 🇬🇧
Richmond Pharmacology Ltd, London, United Kingdom
Real World Evidence Study in Subjects With Wilson's Disease
- Conditions
- Wilson Disease
- First Posted Date
- 2023-03-24
- Last Posted Date
- 2025-07-03
- Lead Sponsor
- Orphalan
- Target Recruit Count
- 50
- Registration Number
- NCT05783687
- Locations
- 🇺🇸
UC Davis Midtown Ambulatory Care Centre, Sacramento, California, United States
🇺🇸Yale University School of Medicine, New Haven, Connecticut, United States
🇺🇸University of Miami, Miami, Florida, United States
International Wilson's Disease Patient Registry (iWilson Registry)
- Conditions
- Wilson's Disease
- First Posted Date
- 2022-02-15
- Last Posted Date
- 2025-07-03
- Lead Sponsor
- Orphalan
- Target Recruit Count
- 500
- Registration Number
- NCT05239858
- Locations
- 🇧🇪
University Hospital Leuven, Leuven, Belgium
🇫🇷Hospices Civils de Lyon, Bron, Auvergne-Rhone-Alpes, France
🇫🇷HF Adolphe de Rothschild, Paris, Île-de-France, France
Trientine Tetrahydrochloride (TETA 4HCL) for the Treatment of Wilson's Disease
- Conditions
- Wilson Disease
- Interventions
- First Posted Date
- 2018-05-30
- Last Posted Date
- 2025-07-02
- Lead Sponsor
- Orphalan
- Target Recruit Count
- 77
- Registration Number
- NCT03539952
- Locations
- 🇺🇸
Yale University School of Medicine, New Haven, Connecticut, United States
🇧🇪KU Leuven, Department of Clinical and Experimental Medicine, Leuven, Belgium
🇧🇷Hospital Nossa Senhora das Graças (HNSG), Curitiba, Brazil
News
Orphalan Makes History as First European Company to Enter China's Wilson Disease Market with "Ke Pei Ou"
• Orphalan has launched trientine tetrahydrochloride ("Ke Pei Ou") in China through a strategic partnership with SPH Kyuan Trade, becoming the first European company to introduce an orphan drug for Wilson disease in this market. • The treatment addresses a critical unmet need for Chinese Wilson disease patients who cannot tolerate penicillamine, the previous standard therapy, offering an alternative that is already available in over 20 countries globally. • Orphalan has established a local entity in Shanghai led by Grace Li as General Manager, demonstrating its commitment to ensuring Chinese patients and healthcare providers have access to advanced Wilson disease treatment options.