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Monoclonal Antibody Therapy Against Chronic Herpes Simplex Virus 2 Infection

NCT04165122 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 122

Last updated 2022-01-18

No results posted yet for this study

Summary

This is a randomized, double-blind, double-dummy study of single dose HDIT101 versus Standard of Care Valaciclovir.

HSV-2-positive patients with at least 4 anogenital herpes lesions in the last 12 months (or at least 2 herpes lesions with previous valaciclovir long-term therapy) can be included.

If a patients develops a anogenital Herpes lesion within 4 months after the screening visit, the patients will be randomized in a 2:1 ratio to HDIT i.v. infusion + episodic treatment with 500 mg Valaciclovir-placebo OR to a single HDIT placebo infusion + episodic treatment with 500 mg Valaciclovir orally bid for 3 days.

Study duration per patient will be 180 days starting with the randomization visit. In addition to the randomization visit, 4 visits at the site and 2 phone calls are scheduled.

At every occurence of a herpetic lesion during the study, patients are treated with Valaciclovir/ Valaciclovir-placebo and need to present at the site twice to document start and end date of the lesion (unscheduled visits).

Conditions

  • Herpes Genitalis

Interventions

BIOLOGICAL

HDIT101

i.v. Infusion

DRUG

Valaciclovir

oral application of encapsulated Valaciclovir tablets

BIOLOGICAL

HDIT101 placebo

i.v. Infusion

DRUG

Valaciclovir placebo

oral application of encapsulated Valaciclovir placebo tablets

Sponsors & Collaborators

  • Heidelberg ImmunoTherapeutics GmbH

    lead INDUSTRY

Principal Investigators

  • Stefan Schoeffel · Heidelberg ImmunoTherapeutics GmbH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-15
Primary Completion
2021-08-25
Completion
2021-11-01

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04165122 on ClinicalTrials.gov