An Open Label Extension Study to Evaluate the Safety of Continued Therapy of Subcutanous Remodulin® in Pulmonary Arterial Hypertension

United Therapeutics

Status and phase: Withdrawn; Phase 4

Conditions: Pulmonary Arterial Hypertension

Treatments: Drug: Subcutaneous Treprostinil

Study type: Interventional

Funder types: Industry

Identifiers

NCT02882126

CVT-CV-004

Details and patient eligibility

About

This is a multicenter, open-label trial to evaluate the safety of continued therapy with subcutaneous Remodulin® in subjects with pulmonary arterial hypertension (PAH) who complete the CVT-CV-003 study. The study will include about 50 subjects at up to 10 clinical trial centers in China who completed all required assessments in the CVT-CV-003 study. Study visits for data collection will occur at month 6 and 12 with yearly visits beyond 12 months until the study is discontinued by the sponsor.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

A subject is eligible for inclusion in this study if all of the following criteria apply:

1. The subject voluntarily gives written informed consent to participate in the study.

2. The subject participated in and completed study CVT-CV-003.

3. Sexually active women of childbearing potential must practice true abstinence from intercourse when it is in line with their preferred and usual lifestyle, or use two different forms of highly effective contraception. Medically acceptable forms of effective contraception include: (1) approved hormonal contraceptive (such as birth control pills), (2) barrier methods (such as a condom or diaphragm) used with a spermicide, (3) an intrauterine device (IUD), or (4) partner vasectomy. Women of child bearing potential include any females who have experienced menarche and who have not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or are not postmenopausal (defined as amenorrhea for at least 12 consecutive months).

   Males participating in the study must use a condom during the length of the study, and for at least 48 hours after discontinuing study medication.

4. The subject has not developed a concurrent illness or condition during the conduct of the previous study (including but not restricted to, sleep apnea, chronic renal insufficiency, anemia, uncontrolled systemic hypertension or left sided heart disease) that would make participation in this study detrimental to the subject's health in the opinion of the Investigator.

5. In the opinion of the Principal Investigator, the subject is able to communicate effectively with study personnel, is considered reliable, willing and likely to be cooperative with protocol requirements, including attending all study visits, and is mentally and physically capable of administering Remodulin by continuous SC infusion using a micro infusion pump.

Exclusion criteria

A subject is not eligible for inclusion in this study if any of the following criteria apply:

1. The subject permanently discontinued Remodulin during study CVT-CV-003.
2. The subject is pregnant or lactating.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Subcutaneous Treprostinil

Experimental group

Description:

Open-label access; The initial dose of Remodulin for this study will be the same as each subject's final dose in study CVT-CV-003. Dose modification will be based according to clinical response and tolerability.

Treatment:

Drug: Subcutaneous Treprostinil