NCT00143416CompletedPhase 3
Long-Term Study of B2036-PEG in Acromegaly - Long Term Study With B2036-PEG -
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Pfizer
- Enrollment
- 16
- Locations
- 9
- Primary Endpoint
- To evaluate the safety and efficacy of long-term B2036-PEG therapy in patients with acromegaly
Study Overview
Brief Summary
Primary objective: To investigate the efficacy and safety of Pegvisomant in Japanese patients with acromegaly.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients with acromegaly who have received at least one dose of B2036-PEG in the preceding study (A6291009).
Exclusion Criteria
- •Switching to other therapeutic methods for acromegaly
Outcomes
Primary Outcomes
To evaluate the safety and efficacy of long-term B2036-PEG therapy in patients with acromegaly
Secondary Outcomes
- PK/PD evaluation
Investigators
Study Sites (9)
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