Search / Trial NCT06235775

Administration of GV1001 for the Treatment of Progressive Supranuclear Palsy Who Completed Study GV1001-PSP-CL2-011

Launched by GEMVAX & KAEL · Jan 23, 2024

Trial Information

Current as of October 08, 2024

Recruiting

Keywords

Progressive Supranuclear Palsy Gv1001

Description

In GV1001-PSP-CL2-011 study, subjects who were in the trial group (Study Group 1(GV1001 0.56 mg/day), Study Group 2(GV1001 1.12 mg/day) is alternately administered High-dose test drug(GV1001 1.12 mg/day) and placebo once a week from Ex-Visit 1(Visit 16, Week 26) to Ex-Visit 5(Visit 20, Week 30) and High-dose test drugs(GV1001 1.12 mg/day) are administered from Ex-Visit 6 (Visit 21, Week 32) to Ex-Visit 26(Visit 41, Week 72) every two weeks. In the GV1001-PSP-CL2-011 study, subjects who were in the placebo group are administered placebo at Ex-Visit 1 (Visit16, Week26), the first visit of th...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • * A person who has been registered in the GV1001-PSP-CL2-011 clinical trial and has completed administration by Week 24
  • * A patient who accompanied all visits with the subject for the scheduled visit of this clinical trial, has a guardian who can supervise the subject's compliance with the examination and examination procedures conducted at the time of the visit, and provides information on the subject's indications, and whose guardian has agreed in writing to participate in the clinical trial (except where it is unnecessary to accompany the guardian at the discretion of the investigator)
  • * Patient and/or representative of the patient who has voluntarily agreed in writing to participate in this clinical trial
  • Exclusion Criteria:
  • * Patients deemed unsuitable by the investigator to participate in this extension study
  • * Pregnant or male subjects who do not consent to contraception by medically approved methods (surgical infertility, intrauterine contraceptive devices, fallopian tube ligature, double blocking (combined use of male condoms, female condoms, cervical caps, contraceptive diaphragm and sponges) and 90 days after clinical trial participation However, women who have undergone menopause or surgical infertility procedures (such as vasectomy and difficult conception on both sides) before participating in clinical trials can participate without consent to contraception.
  • * Pregnant women or breastfeeding women

About Gemvax & Kael

Gemvax & Kael is a biotechnology company dedicated to advancing innovative therapeutic solutions through rigorous research and development. With a focus on immunotherapy and precision medicine, the company aims to address unmet medical needs in oncology and autoimmune diseases. Gemvax & Kael leverages cutting-edge science and a collaborative approach to drive clinical trials that explore novel treatment modalities, ultimately striving to enhance patient outcomes and improve the quality of life for individuals facing complex health challenges.

Locations

Seoul, , Korea, Republic Of

Seoul, , Korea, Republic Of

Seoul, , Korea, Republic Of

Seoul, , Korea, Republic Of

Seongnam Si, , Korea, Republic Of

Seoul, , Korea, Republic Of

Seongnam Si, , Korea, Republic Of

Seoul, Jongno Gu, Korea, Republic Of

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0