A dose finding study in Hump-nosed pit viper bites with new antivenom

A Phase II dose finding study in Hypnale spp with New Polyvalent Snake Antivenom (ICP-AVRI-UOP Sri Lanka polyspecific antivenom)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

SLCTR

Registry ID

SLCTR/2016/015

Enrollment

Unknown

Registered

2016-06-15

Start date

2016-07-13

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypnale Spp Snakebites

Interventions

The study will be conducted in toxicology ward of Teaching hospital Peradeniya. Participants meeting inclusion/exclusion criteria will be allocated to treatment groups (dosing level) mentioned below,

Eligibility

Inclusion criteria

Inclusion criteria: Patients with selected clinical manifestations of envenoming by Hypnale spp. (swelling of the bitten limb with pain and/or blister formation).

Exclusion criteria

Exclusion criteria: 1. <14 years of age 2. Pregnancy 3. Already received antivenom, fresh frozen plasma (FFP), or pre-medication such as adrenaline, hydrocortisone or promethazine at the primary hospital 4. History of allergy to antivenom 5. Inability to give direct or proxy consent (unconscious and unaccompanied by a relative) 6. Presentation more than 8 hours after snake bite.

Design outcomes

Primary

Measure	Time frame
1) Free venom concentration in blood serum [Primary outcome will be measured at 6, 12, 18, 24 and 48 hours after the initiation of antivenom and daily until dischargeweeks after discharge from the hospital ]	—

Secondary

Measure	Time frame
(1) Clotting factors concentrations (Activated partial thromboplastin time [aPTT] fibrinogen, X, V, VII, VIII, D-dimer) (2) Hematological parameters: Hemoglobin concentration, haematocrit, white cell count, platelet count (3) Urinary markers of acute kidney injury (Neutrophil gelatinase-associated lipocalin, beta2-microglobulin, Kidney Injury Molecule-1) (4) Surrogate markers of Myotoxicity as assessed by creatine kinase (CK) (5) Surrogate markers of Renal toxicity as assessed by Neutrophil gelatinase-associated lipocalin, beta2-microglobulin, Kidney Injury Molecule-1 and serum creatinine (6) Pain Score (using a visual analogue scale) (7) Duration of hospital stay [Secondary outcomes 1-6 will be measured at 6, 12, 18, 24 and 48 hours after the initiation of antivenom and daily until discharge Secondary outcome 7 will be measured as the time of initiation of AVS to time of discharge from the hospital ]	—

Measure

Time frame

(1) Clotting factors concentrations (Activated partial thromboplastin time [aPTT] fibrinogen, X, V, VII, VIII, D-dimer) (2) Hematological parameters: Hemoglobin concentration, haematocrit, white cell count, platelet count (3) Urinary markers of acute kidney injury (Neutrophil gelatinase-associated lipocalin, beta2-microglobulin, Kidney Injury Molecule-1) (4) Surrogate markers of Myotoxicity as assessed by creatine kinase (CK) (5) Surrogate markers of Renal toxicity as assessed by Neutrophil gelatinase-associated lipocalin, beta2-microglobulin, Kidney Injury Molecule-1 and serum creatinine (6) Pain Score (using a visual analogue scale) (7) Duration of hospital stay [Secondary outcomes 1-6 will be measured at 6, 12, 18, 24 and 48 hours after the initiation of antivenom and daily until discharge Secondary outcome 7 will be measured as the time of initiation of AVS to time of discharge from the hospital ]

—

Countries

Sri Lanka

Contacts

Public ContactProfessor Indika Bandara Gawarammana

Professor in Medicine

indikagaw@gmail.com+94814479822

Outcome results

None listed

Source: SLCTR (via WHO ICTRP) · Data processed: Aug 9, 2026