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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02882126
• Date of registration: 24/08/2016
• Prospective Registration: Yes
• Primary sponsor: United Therapeutics
• Public title: An Open Label Extension Study to Evaluate the Safety of Continued Therapy of Subcutanous Remodulin® in Pulmonary Arterial Hypertension
• Scientific title: An Open-Label Extension Trial to Evaluate the Safety of Continued Therapy With Subcutaneous Remodulin® in Subjects With Pulmonary Arterial Hypertension Who Completed Study CVT-CV-003
• Date of first enrolment: June 2017
• Target sample size: 0
• Recruitment status: Withdrawn
• URL: https://clinicaltrials.gov/show/NCT02882126
• Study type: Interventional
• Study design: Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

China

Contacts

• Name: Junbo Ge
• Affiliation: Zhongshan Hospital affiliated with Fudan University

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Pulmonary Arterial Hypertension

Intervention(s)

Drug: Subcutaneous Treprostinil

Primary Outcome(s)

Incidence of Adverse Events Among Subjects through Study Completion [Time Frame: Study Completion, an Average of 3 Years]

Number of Participants with a Change from Baseline World Health Organization (WHO) Functional Classification at Month 12 [Time Frame: Change from Baseline at Month 12]

Change in 6-minute Walk Distance (6MWD) From Baseline to Month 12 [Time Frame: Baseline and Month 12]

Change in Borg Dyspnea Score (following 6MWT) from Baseline to Month 12 [Time Frame: Baseline and Month 12]

Secondary ID(s)

CVT-CV-004

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

CVie Therapeutics Co. Ltd.