Cidofovir for laryngeal papillomatosis

JRCT ID: jRCTs041180032

Registered date:29/01/2019

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: recurrent respiratory papillomatosis
• Date of first enrollment: 15/10/2014
• Target sample size: 20
• Countries of recruitment: Not applicable,Japan
• Study type: Interventional

Intervention(s)

1.Evaluation of the general condition including renal function before operation.
2.Local injection to the laryngeal papillomatosis under general anesthesia third times every two weeks.
3.Single therapy, the resection and local injection of the cidofovir, can be performed when the recurrent resion was found after 3 months from the third time injection of cidofovir.
4.At first, single therapy can be performed to the patient has been administerd the cidofovir in the other clinical trial.

Outcome(s)

• Primary Outcome: Time to progression
• Secondary Outcome: The safety of intralesional cidofovir injection, response rate to cidofovir

Key inclusion & exclusion criteria

• Age minimum: >= 16age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Laryngeal papillomatosis diagnosed by laryngeal fiber scope and histopathological examination.
2. Adequate organ function:
1) White blood cells > 2,500/mm3
2) Neutrophils > 1,250/mm3
3) Platelet > 75,000/mm3
4) GOT < 100 IU/L, ALT < 100IU/L
5) Serum creatinine < 1.5 mg/dL
3. Written informed consent

Exclude criteria

1.Renal dysfunction: serum createnin more than 1.5 mg/dL
2.Nephrotoxic drug administration
3.An allergy to cidofovir
4.An allergy to probenecid or sulfa drug
5.Pregnant, unwilling to practice contraception during the study, or lactating female
6.Inappropriate decided by doctor

Related Information

• Primary Sponsor: YOSHIZAKI Tomokazu
• Secondary ID(s): UMIN000020350