Observational Study Providing 12 Months of Safety Follow-Up From First Exposure to HP802-247

Healthpoint

Status: Completed

Conditions: Venous Leg Ulcer (VLU)

Treatments: Biological: No treatment; Biological: No treatment specified

Study type: Observational

Funder types: Industry

Identifiers

NCT01970657

802-247-09-033

Details and patient eligibility

About

This observational safety follow-up study enrolled subjects from the 802-247-09-032 study with the investigational product HP802-247 for venous leg ulcers, who received at least one application of HP802-247 or Vehicle (Placebo). This study is being done for the following purposes:

1. to identify new adverse events,
2. to examine ongoing adverse events not resolved in subjects who participated in the 802-247-09-032 trial,
3. to record wound status, and
4. to determine if there are differences in Health Related Quality of Life (HRQoL) associated with the treatment assignment from the 802-247-09-032 Trial.

About 440 subjects were to participate depending upon subject enrollment from the previous study, 802-247-09-032. The study was conducted in approximately 50 sites in Europe.

Full description

Subjects transitioned to this observational study immediately upon exit from the 802-247-09-032 trial. This ensured a total of 12 months of safety observations and wound status data were obtained from the time of the first application of HP802-247. This study provided consecutive visits at intervals of 8 weeks until a total of 12 months of safety follow-up had been achieved, based on the initial application of Investigational Medicinal Product in the prior study. Specifically, this study examines all new and unresolved ongoing adverse events.

Enrollment: 221 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• The informed consent document must be read, signed, and dated by the subject or the subject's legally authorized representative before conducting any study procedures or exams.
• Subject was randomized in 802-247-09-032 and received at least one application of test article.
• Subject has ended their participation in 802-247-09-032 by virtue of completing the study, or by dropping out prior to completion.

Exclusion criteria

• Subjects who refuse to provide written informed consent for this study will be excluded from this study.

Trial design

221 participants in 2 patient groups

HP802-247 in prior study

Description:

Observational safety follow up study, no treatment specified

Treatment:

Biological: No treatment specified

Vehicle Control in prior study

Description:

Observational safety follow up study, no treatment specified

Treatment:

Biological: No treatment