Vitalgen has initiated and carried out a “Clinical study to evaluate the safety and tolerability of VGB-R04 in adult hemophilia B patients" at Hematology Hospital, Chinese Academy of Medical Sciences, and is currently recruiting.
The recruitment requirements are as follows:
1. Male, ≥18 years old, ≤75 years old;
2. Clinically confirmed hemophilia B patients, with clinical laboratory examination showing the endogenous FIX activity levels ≤2 IU/dL (≤ 2%) (previous examination results can be accepted);
3. Contraceptive requirements: Fertile subjects must agree to use reliable contraceptive methods until at least one year after the injection of VGB-R04 and the sperms arevector genome negative in two consecutive tests;
4. Patients had no clinically confirmed liver diseases within 6 months prior to the screening.
Enrollment process: Patient registration, data review, followed by blood collection notification, and only patients who pass the blood test will be enrolled in the study;
Method of treatment: Single dose intravenous infusion, with follow-up visit to the hospital for long-term observation required;
Reimbursement: at no cost to patients, with the cost of laboratory, transportation and accommodation to be covered or reimbursed..
If you have any questions, please feel free to contact the following doctor for consultation. Thank you for your contribution to hemophilia gene therapy.
Name：Bi Tingting
Telephone：17640124439
Address：Hematology Hospital, Chinese Academy of Medical Sciences, 288 Nanjing Road, Heping District, Tianjin, China
Vitalgen has initiated and carried out a “Safety and Tolerability of VGR-R01 in Patients with Bietti Crystalline Dystrophy" at Capital Medical University affiliated Beijing Tongren Hospital, and this clinical study is currently recruiting.
The key recruitment requirements are as below:
1.Male, ≥18 years and ＜80 years of age;
2.Confirmed diagnosis of Bietti Crystalline Dystrophy, with molecular diagnosis of CYP4V2 mutations (homozygotes or compound heterozygotes);
3.Best Corrected Visual Acuity ≤ 20/200, -8 D ＜diopters＜ +8 D, 21 mm < axial lengths ≤ 28 mm in the study eye;
4.Contraceptive requirements: Fertile subjects must agree to use reliable contraceptive methods until at least one year after the injection of VGR-R01;
5.Has no clinically significant liver diseases;
6.Has no clinically significant systemic diseases.
Enrollment process: Patient registration, data review, followed by blood collection notification, and only patients who pass the blood test will be enrolled in the study;
Method of treatment: Single dose subretinal injection, and long-term follow-up observation was required;
Reimbursement: No cost was needed from the patients. The cost of laboratory tests, transportation and accommodation will be covered or reimbursed.
If you have any questions, please feel free to contact the following doctor for consultation. Thank you for your contribution to BCD gene therapy.
Name：Doctor wang ; Wechat：13683178767
Name：Doctor Zhang ; Telephone：13552757069
Address：1 Dongjiaomin Alley, Dongcheng District, Beijing, China
