GEN-EXTEND
Completed
GEN-EXTEND is the open-label extension study for the Phase 3 trial, GENERATION HD1. Whereas GENERATION HD1 is designed to evaluate the effects of Roche’s HD treatment and help decide if it should be made available to patients, GEN-EXTEND evaluates the long-term safety of the same treatment, to understand long-term side effects. Not everyone is able to be a part of this study, only patients who have been involved in the earlier trials in the programme can join an open-label extension.
Estimated Study Completion Date: March 25, 2022
Ages Eligible for Study
25 Years to 65 Years (Adult, Older Adult)
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- Prior enrollment in a Roche-sponsored or Genentech-sponsored study in HD for the GENERATION-HD clinical trial program.
- For women of childbearing potential: agreement to remain abstinent or use contraceptive measures
- For men: agreement to remain abstinent or use a condom, and agreement to refrain from donating sperm
- Patients who were screened and eligible for the placebo-controlled Phase III Study BN40423 but could not be randomized prior to the close of Study BN40423 enrollment due to challenges relating to the COVID-19 pandemic
Exclusion Criteria:
- Any serious medical condition or clinically significant laboratory, or vital sign abnormality or claustrophobia at screening that, in the investigator’s judgment, precludes the patient’s safe participation in and completion of the study
- Pregnant or breastfeeding, or intending to become pregnant during the study or within 5 months after the final dose of study drug