Clinical trial NCT02882126: An Open Label Extension Study to Evaluate the Safety of Continued Therapy of Subcutanous Remodulin® in Pulmonary Arterial Hypertension
Official 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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Pulmonary Arterial Hypertension
Keywords: PAH
Subcutaneous Treprostinil
Remodulin
6 Minute Walk Test
Lead sponsor: United Therapeutics
Sponsor class: INDUSTRY
Collaborators: name: CVie Therapeutics Co. Ltd.
First posted: 2016-08-29
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: Incidence of Adverse Events Among Subjects through Study Completion
timeFrame: Study Completion, an Average of 3 Years
measure: Change in 6-minute Walk Distance (6MWD) From Baseline to Month 12
timeFrame: Baseline and Month 12
measure: Change in Borg Dyspnea Score (following 6MWT) from Baseline to Month 12
timeFrame: Baseline and Month 12
measure: Number of Participants with a Change from Baseline World Health Organization (WHO) Functional Classification at Month 12
timeFrame: Change from Baseline at Month 12
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Chao-Yang Hospital
city: Beijing
country: China
facility: Beijing Anzhen Hospital, Capital Medical University
city: Beijing
country: China
facility: Peking Union Medical College Hospital
city: Beijing
country: China
facility: Fu Wai Hospital
city: Beijing
country: China
facility: Beijing Shijitan Hospital
city: Changsha
country: China
facility: Xiangya Hospital Centre South University
city: Guangzhou
country: China
facility: Guangdong General Hospital
city: Shanghai
country: China
facility: Zhongshan Hospital affiliated with Fudan University
city: Shanghai
country: China
facility: Shanghai Pulmonary Hospital
city: Wuhan
country: China
facility: Wuhan Asia Heart Hospital
Study officials:
affiliation: Zhongshan Hospital affiliated with Fudan University
name: Junbo Ge
role: PRINCIPAL_INVESTIGATOR
References: