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

Last updated: May 8, 2017
Sponsor: United Therapeutics
Overall Status: Trial Not Available

Phase

4

Condition

Circulation Disorders

Williams Syndrome

Vascular Diseases

Treatment

N/A

Clinical Study ID

NCT02882126
CVT-CV-004
  • Ages > 18
  • All Genders

Study 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

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 fromintercourse when it is in line with their preferred and usual lifestyle, or use twodifferent forms of highly effective contraception. Medically acceptable forms ofeffective contraception include: (1) approved hormonal contraceptive (such as birthcontrol pills), (2) barrier methods (such as a condom or diaphragm) used with aspermicide, (3) an intrauterine device (IUD), or (4) partner vasectomy. Women of childbearing potential include any females who have experienced menarche and who have notundergone successful surgical sterilization (hysterectomy, bilateral tubal ligation orbilateral 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, andfor at least 48 hours after discontinuing study medication.

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

  5. In the opinion of the Principal Investigator, the subject is able to communicateeffectively with study personnel, is considered reliable, willing and likely to becooperative with protocol requirements, including attending all study visits, and ismentally and physically capable of administering Remodulin by continuous SC infusionusing a micro infusion pump.

Exclusion

Exclusion Criteria: A subject is not eligible for inclusion in this study if any of the following criteriaapply:

  1. The subject permanently discontinued Remodulin during study CVT-CV-003.

  2. The subject is pregnant or lactating.

Study Design

Study Start date:
June 01, 2017
Estimated Completion Date:
June 30, 2021

Connect with a study center

  • Beijing Anzhen Hospital, Capital Medical University

    Beijing, 100029
    China

    Site Not Available

  • Beijing Chao-Yang Hospital

    Beijing, 100020
    China

    Site Not Available

  • Beijing Shijitan Hospital

    Beijing, 100038
    China

    Site Not Available

  • Fu Wai Hospital

    Beijing, 100037
    China

    Site Not Available

  • Peking Union Medical College Hospital

    Beijing, 100032
    China

    Site Not Available

  • Xiangya Hospital Centre South University

    Changsha, 410008
    China

    Site Not Available

  • Guangdong General Hospital

    Guangzhou, 510080
    China

    Site Not Available

  • Shanghai Pulmonary Hospital

    Shanghai, 200433
    China

    Site Not Available

  • Zhongshan Hospital affiliated with Fudan University

    Shanghai, 200032
    China

    Site Not Available

  • Wuhan Asia Heart Hospital

    Wuhan, 430022
    China

    Site Not Available

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