Dose Escalation Study With QLT0074 for Benign Prostatic Hyperplasia

Completed · Phase 1/Phase 2

Conditions studied: Benign Prostatic Hyperplasia

In brief

The primary objective of this study is to assess the safety and tolerance of transurethral photodynamic therapy (PDT) with QLT0074. Secondary objectives are: 1. To determine if transurethral PDT with QLT0074 has a therapeutic effect on benign prostatic hyperplasia (BPH), evaluated by the American Urological Association Symptom Index (AUA SI), urinary flow rate (Qmax), and post-void residual volume (PVR). 2. To determine the extent of systemic exposure to QLT0074 following transurethral intraprostatic injection. 3. To select up to two transurethral PDT drug-light regimens for further clinical development.

Key facts

Study ID

NCT00077012

Run by

QLT Inc.

Starts

2003-03-01

Expected to finish

2005-05-01

Last updated by the study team

2012-05-23

Who can join

Age: any. Sex: male. Healthy volunteers: not accepted.

Where it is running

• Raymond Fay, MD, Inc — San Francisco, California, United States
• George Washington University Medical Center — Washington D.C., District of Columbia, United States
• Advanced Research Institute Inc — New Port Richey, Florida, United States
• Carolina Urologic Research Center — Myrtle Beach, South Carolina, United States
• North Texas Veteran Affairs Health Care System — Dallas, Texas, United States
• The Prostate Centre at Vancouver General Hospital — Vancouver, British Columbia, Canada
• Royal Victoria Hospital — Montreal, Quebec, Canada

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.