Compassionate Administration of ZVS101e for Extended Treatment
Condition(s) studied
Investigational drug(s) / intervention(s)
ZVS101e: ZVS101e is a recombinant adeno-associated virus serotype 8 (rAAV8) vector expressing human CYP4V2 protein
Study summary
To provide treatment options for the control group of subjects who completed the 52-week follow-up of the Phase III clinical trial (Protocol number: ZYA-2024-001) of ZVS101e in subjects with Bietti crystalline corneoretinal dystrophy (BCD).
Eligibility
Primary outcome measure(s)
- Incidence and severity of adverse events and serious adverse events — 4 weeks
This study specifies that the recording of adverse events begins on Day 0 (D0). Adverse events (AEs) include, but are not limited to, the following: 1. Worsening of pre-existing medical conditions/diseases (i.e., conditions present prior to enrollment in the clinical trial), including exacerbation of symptoms, signs, frequency of episodes, or abnormal laboratory test results; 2. Any newly occurring adverse medical conditions (including symptoms, signs, or newly diagnosed diseases); 3. Abnormal laboratory test values or results with clinical significance, or other safety assessments (e.g., vital signs measurements).
Trial sites (5)
| Facility | City | Region | Status |
|---|---|---|---|
| Peking University Third Hospital | Beijing | Beijing Municipality | |
| Zhongshan Ophthalmic Center, Sun Yat-sen University | Guangzhou | Guangdong | |
| Henan Provincial People's Hospital | Zhengzhou | Henan | |
| West China Hospital, Sichuan University | Chengdu | Sichuan | |
| Tianjin Medical University Eye Hospital | Tianjin | Tianjin Municipality |
More Chigenovo Co., Ltd trials in China
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07307469 on ClinicalTrials.gov ↗ ← All trials in China